Dr. Joe W. Gray
MS 84R0171
1 Cyclotron Road
Berkeley, CA 94720-
Phone: 510-486-2438
Fax: 510-486-2535
E-mail: jwgray@lbl.gov
Number of Human Subjects projects reported: 43
| LBNL-75-001-H02 | "Experimental Medicine Clinical" |
| LBNL-77-057-H02 | "Studies of Lipoproteins and Lipid Protein Interactions" |
| LBNL-79-108-H01 | "hTERT Reactivation During Immortalization of Human Cells " |
| LBNL-80-001-H01 | "Myocardial Flow, Function, and Metabolism by PET and MRI " |
| LBNL-84-001-H03 | "Alzheimer's Disease as a Systemic Disorder" |
| LBNL-91-107-H01 | "National Runners and Walkers Health Study" |
| LBNL-92-107-H05 | "Gene Specific Responses to Exercise in Discordant Twins (Formerly, "Effects of Running on HDL and LDL Subclasses of MZ Twins")" |
| LBNL-98-107-H06 | "National Health Survey on the Internet" |
| LBNL-98-139-H01 | "Breast Cancer Specific PET Instrumentation" |
| LBNL-99-107-H07 | "Effects of Genes on the Relationship of Lifestyle to Disease" |
| LBNL-00-005-H01 | "Training in Mammary Gland Biology and Breast Cancer" |
| LBNL-00-143-H01 | "Novel Functions for Red Cell Proteins Lu and LW" |
| LBNL-01-063-H01 | "Estrogen Receptors in the Brain" |
| LBNL-01-109-H02 | "Indoor Bioaerosol Detection and Quantification by Polymerase Chain Reaction (PCR)" |
| LBNL-02-107-H08 | "Validating Dietary Assessment on the Internet" |
| LBNL-02-109-H03 | "Thermal Comfort of a Task Ventilation System (Formerly, Task Ventilation Optimization)" |
| LBNL-02-186-H01 | "Chelation Therapy Using Calcium DTPA and/or Zinc DTPA for Internal Contamination with Plutonium and Other Transuranic Elements" |
| LBNL-03-05H21 | "Undergraduate Training in Mammary Gland Biology and Breast Cancer" |
| LBNL-03-130-H04 | "Nu 99G8: The National Ovarian Cancer Early Detection Program - Molecular Cytogenetic Detection of Early Cancer" |
| LBNL-03-184H02 | "Improved Cardiac SPECT with Convergent Hole Collimators" |
| LBNL-03-193H01 | "Ergo Arm Support Research and Development - Phase II: Field Testing and Engineering Prototype Refinement" |
| LBNL-03-194H01 | "Advanced Techniques in Latent Fingerprint Detection, Visualization and Analysis" |
| LBNL-03-207-H01 | "Advancing Electrochromic Windows" |
| LBNL-03-85-H04 | "Evaluation of Iodorotenone, a SPECT Perfusion Tracer" |
| LBNL-03-99H01 | "Role of CYP1B1 in PAH-DNA Adduct Formation and Breast Cancer" |
| LBNL-04-107H06 | "Long-Term Exercise Maintenance via Internet Support" |
| LBNL-04-130H02 | "The Biology of Ovarian Cancer: Genome Evolution and Gene Discovery in Ovarian Cancer" |
| LBNL-04-161H02 | "Human DNA Re-Sequencing: Slavotinek Samples" |
| LBNL-04-161H03 | "Human DNA Re-Sequencing: McPherson Obesity Samples" |
| LBNL-04-161H04 | "Human DNA Re-Sequencing: Dr. Joe Gray Collaboration" |
| LBNL-04-161H05 | "Human DNA Re-Sequencing: Melanoma Samples" |
| LBNL-04-161H06 | "Human DNA Re-Sequencing: Read Collaboration" |
| LBNL-04-161H07 | "Human DNA Re-Sequencing: McPherson Samples (Coronary Artery Disease)" |
| LBNL-04-184-H03 | "Dynamic Cardiac SPECT Imaging" |
| LBNL-04-184-H04 | "Improved Cardiac SPECT with Convergent Hole Collimators" |
| LBNL-04-185-H03 | "Review of Geographically-Referenced Data for Air Pollution and Health Research in California" |
| LBNL-04-189H01 | "Classroom HVAC: Improving Ventilation and Saving Energy" |
| LBNL-04-207-H02 | "Cost-Effective Daylighting Solutions" |
| LBNL-04-213H01 | "Comparative Community Genomics of the Gut Microbiota" |
| LBNL-04-223H01 | "DNA Repair in Artemis Deficiency" |
| LBNL-04-225H01 | "The rSBH System for Comprehensive Pathogen Diagnostics" |
| LBNL-04-73H01 | "Brain Imaging with [F18]-Fluorodeoxyglucose (FDG) in Adult Males and Females -New Methods for Analyzing PET Data" |
| LBNL-04-85-H01 | "Brain Imaging with [F-18]-Fluorometatyrosine in Adult Males and Females: Implications for Parkinson's Disease" |
"Experimental Medicine Clinical"
Principal Investigator: Dr. Thomas F. Budinger, Lawrence Berkeley National Laboratory
Project started in: 1975
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 9
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 10/17/03
IRB approval number: 2003-10-85
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: PET Study of Breast Cancer
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in detecting the presence and size of primary and metastatic breast cancer. The LBNL procedures are to be applied twice, once during the initial visit, then two to four months following this initial scan. The subject may benefit from the detection of the presence of metastasis. Society may benefit from an improved technique for the diagnosis and management of future breast cancer patients.
METHODOLOGY
A catheter will be placed in a vein in one arm to inject the radiotracer. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last as long as 120 minutes. A second scan will be performed two to four months following the initial scan to evaluate progression of the disease for subjects off therapy or therapeutic response for subjects who are receiving therapy.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose (FDG-18)
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); internal exposure to radiation (equivalent to kidney x-ray).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and/or magnetic resonance imaging (MRI) scans are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 06/11/04
IRB approval number: 2004-6-127
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 15
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: "Assessment of Maximum Vasodilatory Reserve and Sensitivity to Ischemia"
OBJECTIVES
The purpose of this study is to evaluate a measure of vasodilatory reserve and sensitivity to ischemia. The method will be evaluated before and after consumption of nicotine or meals of varying composition.
METHODOLOGY
Up to 60 male and female subjects will be recruited by posting advertisements in local newspapers. Half will be assigned to Group 1 (nicotine study) and half to Group 2 (diet study). Subjects with heart disease, vascular conditions, clotting disorders, hypertension, or a recent venipuncture will be excluded. Both groups will fast for 12 hours before being in the study. Subjects in Group 1 will participate up to ten times, and subjects in Group 2 five times.
Core Procedure: The subject's arm will be positioned in a frame. An artificial pulse will be created by using a mechanical device to gently tap the arm throughout the procedure. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for 'O' seconds. The sound of the artificial pulse will be recorded before, during, and for 'M' minutes after the blood pressure cuff is released using a laser Doppler imager. The cuff will be tightened and released three times during each procedure; each cycle of tightening will be longer than the previous one. The value of 'O' will vary from 15 to 300 seconds, and 'M' from 30 to 120 seconds.
Group 1: Subjects will fast for 12 hours before each study. On the day of the study, each subject will receive a brief medical screening. The subject will then have a set of measurements taken using the Core Procedure, will chew nicotine polacrilex gum for about thirty minutes, then have a second set of Core measurements. The dose of nicotine will be similar to or less than used for smoking cessation.
Group 2: Subjects will fast for 12 hours before each study. On the day of the study, each subject will receive a brief medical screening. The subject will then have a set of measurements taken using the Core Procedure, will eat a meal of known fat composition, and then undergo a second set of Core measurements. The meals will vary with each experiment and will include low fat; high fat, low polyunsaturated fat; high fat, high polyunsaturated fat, etc.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Nicotine gum; cream pudding prepared by a nutritionist to meet the fat composition goals of the study.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include the discomfort and the possibility of bruising from the blood pressure cuff and minor irritation from the electrode paste. Subjects are also informed that the use of blood pressure cuffs to block blood supply to the arm has been shown to be safe for up to 30 minutes and that the repeated blocking of the blood supply for much shorter periods might conceivable pose some unanticipated risks. Nicotine gum may cause a burning or tingling sensation in the mouth, nausea, raised blood pressure, heartburn, and headache.
PRIVACY/CONFIDENTIALITY/CONSENT
The identities of the subjects are known, but any public report is by code numbers only. The results of the tests are discussed with the subjects. Subjects are reminded that research records are not immune to subpoena.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 09/02/04
IRB approval number: 2004-6-292
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 09/02/04 to 09/30/04
Explanation:
Initial period of approval falling within fiscal year.
Type(s) of Human Subjects Involvement:
TITLE: "Genetics and Brain Growth"
COLLABORATING INVESTIGATORS: P. Thomas Schoeneman, PhD (University of Pennsylvania); Bruce T Lahn, PhD (University of Chicago); and Kathleen T. Brennan, DVM (LBNL)
OBJECTIVES
The purpose of this study is to build on an earlier project comparing brain size and cognitive ability among 36 female sibling pairs. Under this protocol, cheek swabs will be analyzed for two genes believed to be related to brain size, the abnormal spindle-like microcephally (ASPM) and microcephalin genes. The results will be correlated with cognitive ability and brain-size data previously collected.
METHODOLOGY
The same 72 women who participated in the original study will be recruited. Subjects who consent will be sent a cheek cell sample collection kit, instructions on the kit's use, and a pre-paid mailer for returning the sample.
The cells collected on the swab will be used as sources for DNA. The DNA will only be analyzed for the two genes of interest, ASPN and microcephalin. Material remaining after the analysis will be discarded.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
There is no known risk from use of the cheek swab.
PRIVACY/CONFIDENTIALITY/CONSENT
Subjects will be recruited through direct mail from the LBNL investigators. Included in the package with the letter will be a consent form and a copy of the publication that resulted from the original research. Only subjects who return a signed consent form will be sent a kit for the collection of cheek cells.
The identities of the subjects are known, but any public report is by code numbers only. The results of the tests will not be shared or discussed with the subjects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 08/26/04
IRB approval number: 2004-8-6
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Other: 08/26/04 to 09/30/04
Explanation:
Initial period of approval falling within fiscal year 2004.
Type(s) of Human Subjects Involvement:
TITLE: "TMJ PET Imaging and the Study of Muscular Components of the Face"
OBJECTIVES
To evaluate the efficacy of the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality in imaging the muscles involved in chewing. While there is no direct benefit to the subjects, society as a whole may benefit from an improved technique for the diagnosis and management temporomandibular joint (TMJ) disease.
METHODOLOGY
Up to 30 normal controls, half male and half female, will be recruited by advertising in local newspapers. Potential subjects will be briefly screened over the telephone, then given a more in-depth screening, including a pregnancy test for women, after formally consenting to the research. Each subject will undergo two PET scans of the head and jaw muscles. The first scan will be done at rest; the second scan will be done to two weeks later. Prior to the second scan the subject will chew the gum of their choice for up to four hours, until the muscles of the jaw become fatigued.
The procedure for both scans is the same. Subjects will be given water to drink to provoke urination. A catheter will be placed in a vein in one arm to inject the radiotracer. Immediately prior to entering the scanner, subjects are asked to urinate to keep the radiation dose to the bladder as low as possible. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable. Subjects may not move during the scan, which may last as long as 120 minutes.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Fluorine-18 Fluorodeoxyglucose (FDG-18)
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to nine years of natural background radiation or an x-ray computed tomograph of the abdomen). Chewing gum for an hour or longer may result in jaw pain; if this occurs, the subject will be instructed to stop chewing and will procede immediately to the PET scan.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET and/or magnetic resonance imaging (MRI) scans are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/21/04
IRB approval number: 2004-1-18
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 04/21/04 to 09/30/04
Explanation:
Initial period of approval falling within fiscal year.
Type(s) of Human Subjects Involvement:
TITLE: Quantification of Endothelial Progenitor Cells and White Cell Metabolism in the Normal Population
OBJECTIVES
The researcher hypothesizes that Alzheimer's disease (AD) is a systemic condition. A possible mechanism for the disease may be a defect in the ability of an individual's progenitor endothelial cells to repair the endothelium of capillaries. The goals of this project are to determine the reliability of an assay for progenitor endothelial cells and to study white cell metabolism in normal adults.
METHODOLOGY
An equal number of control subjects and AD patients will be recruited. Patient subjects are accompanied by an adult family member or guardian to assure an appropriate consent process. AD patients will have been previously evaluated by their treating clinic and these results will be made available to the researchers.
Up to 30 normal subjects, half male and half female, will be recurited by advertising in local papers. The subjects will come to Berkeley Laboratory, where they will be screened for serious systemic disease and have a 20 cc sample of venous blood drawn. After testing, the subjects blood sample will be discarded.
IONIZING RADIATION, RADIOACTIVE OR CHEMICAL SUBSTANCES None
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include those common to a routine venous blood draw: bruising, faintness, and very rarely, infection.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Blood samples are coded, and only the researcher has access to the code key. The results from the blood tests are not provided to subjects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 03/05/04
IRB approval number: 2004-3-67
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 9
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Evaluation of a New Instrument for the Assessment of Vascular Function
OBJECTIVES
The purpose of this study is to compare how well two different devices measure blood flow in the arteries of the arm. The goal is to produce a small, low-cost device that could be used as part of a routine medical check-up to evaluate arterial health.
METHODOLOGY
Up to 30 male and female subjects will be recruited by posting advertisements in local newspapers. Subjects with heart disease, vascular conditions, clotting disorders, hypertension, or a recent venipuncture will be excluded. Each subject will be examined with both the relaxoscope (Device A, the test device) and B-mode/M-mode procedure (Device B, the current standard).
On the day of the study, each subject will receive a brief medical screening. The first 15 subjects will be tested with Device B first, and the second 15 with Device A first. After completion of the first test, subjects will wait about an hour and then be tested with the second device.
Device A procedure: The subject's arm will be positioned in a frame. An artificial pulse will be created by using a mechanical device to gently tap the arm throughout the procedure. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for four to six minutes. The sound of the artificial pulse will be recorded before, during, and for ten minutes after the blood pressure cuff is released using a Doppler stethoscope.
Device B procedure (the current standard): The subject's arm will be positioned in a different frame. Electrocardiogram (EKG) electrodes will be attached. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for about four minutes. Variation of the arterial diameter will be measured before, during, and after release of the blood pressure cuff.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include:
Device A -- Discomfort and the possibility of bruising from the blood pressure cuff; possibility of minor bruising from the tapping device or the frame.
Device B -- Discomfort and the possibility of bruising from the blood pressure cuff and minor irritation from the electrode paste.
PRIVACY/CONFIDENTIALITY/CONSENT
The identities of the subjects are known, but any public report is by code numbers only. The results of the tests are discussed with the subjects. Subjects are reminded that research records are not immune to subpoena and are subject to review by the Food and Drug Administration.
Because of the discomfort associated with wearing a blood pressure cuff tightened over 200 mmHg for four to six minutes, subjects are specifically reminded that they can ask to have the cuff removed at any time.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 03/05/04
IRB approval number: 2004-3-56
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: The Study of Breast Cancer Using C-11 Choline and Positron Emission Tomography
OBJECTIVES
To evaluate the biokinetics of C-11 choline with a view towards its usefulness as a radiotracer for the identification of breast cancer by positron emission tomography (PET). Choline is expected to be preferentially picked up by the tumor because of a known increase in choline kinase in malignant cells as compared to normal tissue.
METHODOLOGY
Up to 30 subjects with breast cancer confirmed through other diagnostic procedures will be recruited through contact with primary care physicians. Results from this scan will be correlated with other imaging modalities (magnetic resonance imaging, ultrasound, etc.) that are given to subjects as part of their clinical care. Prior to the scan, a short medical history of the current disease and an accounting of food consumption during the prior 48 hours will be taken.
A catheter will be placed in a vein in one arm to inject the radiotracer. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last as long as 120 minutes. A second scan will be performed two to twelve months following the initial scan to evaluate changes in biokinetics associated with the subject's status and to determine if the kinetics of tumor uptake corresponds to that expected from other measures of cancer progression or regression.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Internal exposure to Carbon-11 Choline as a radiotracer. (This is a Radioactive Drug Research Committee monitored compound.) External exposure during the PET transmission scan.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); internal exposure to radiation from the tracer(equivalent to kidney x-ray); external exposure from the transmission scan (equivalent to the amount of background radiation the average person receives in one week).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 03/05/04
IRB approval number: 2004-3-55
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: The Study of Prostate Cancer Using C-11 Choline and Positron Emission Tomography
OBJECTIVES
To evaluate the biokinetics of Carbon-11 choline with a view towards its usefulness as a radiotracer for the identification of prostate cancer and its metastasis in positron emission tomography (PET). Choline is expected to be preferentially picked up by the tumor because of a known increase in choline kinase in malignant cells as compared to normal tissue. Choline may also be a better candidate for prostate imaging as it is not expected to collect in the bladder.
METHODOLOGY
Up to 30 subjects with prostate cancer confirmed through other diagnostic procedures will be recruited through contact with primary care physicians. Results from this scan will be correlated with other imaging modalities (magnetic resonance imaging, ultrasound, etc.) that are given to the subject as part of their clinical care. Prior to the scan, a short medical history of the current disease and an accounting of food consumption during the prior 48 hours will be taken.
A catheter will be placed in a vein in one arm to inject the radiotracer. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last as long as 120 minutes. A second scan will be performed two to twelve months following the initial scan to evaluate changes in biokinetics associated with the subject's status and to determine if the kinetics of tumor uptake corresponds to that expected from other measures of cancer progression or regression.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Internal exposure to Carbon-11 Choline as a radiotracer. (This is a Radioactive Drug Research Committee monitored compound.) External exposure during the PET transmission scan.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); internal exposure to radiation from the tracer(equivalent to kidney x-ray); external exposure from the transmission scan (equivalent to the amount of background radiation the average person receives in one week).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Results from PET are supplied to the patients' personal physicians. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 09/20/02
IRB approval number: 2002-4-83
Explanation of IRB approval:
After pending renewal since 4/03, this protocol was discontinued in October 2004.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 09/20/02 to 04/04/03
Explanation:
Final period during which protocol had approval by the institutional review board.
Type(s) of Human Subjects Involvement:
TITLE: Assessment of the Effect of Meal Composition on Vascular Function
OBJECTIVES
The purpose of this research is to study the effects of dietary fat on the short-term function of blood vessels. The researchers will also be testing a new device that measures these effects.
METHODOLOGY
Up to 30 male and female subjects between 21 and 48 years of age will be recruited by posting advertisements in local newspapers. Subjects with heart disease, vascular conditions, clotting disorders, hypertension, or a recent venipuncture will be excluded. Subjects will be asked to participate on five separate occasions.
Subjects will be asked to abstain from use of anti-inflammatory drugs for two days before each experiment and to fast and abstain from the use of products known to affect circulation (i.e., cigarettes, weight-loss medications) for 12 hours. On the day of the experiment, each subject will receive a brief medical screening. Each experiment will consist of a baseline blood sample, a set of baseline readings using both Device A and Device B, followed by consumption of a meal of known fat content, and then a second set of measurements and a second blood sample. The fat and carbohydrate content of the meal will vary for each experiment.
Device A procedure: The subject's arm will be positioned in a frame. An artificial pulse will be created by using a mechanical device to gently tap the arm throughout the procedure. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for four to six minutes. The sound of the artificial pulse will be recorded before, during, and for ten minutes after the blood pressure cuff is released using a Doppler stethoscope.
Device B procedure (the current standard): The subject's arm will be positioned in a different frame. Electrocardiogram (EKG) electrodes will be attached to the hands and right foot. A blood pressure cuff will be applied to the forearm of the subject and tightened to 200 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for about four minutes. Variation of the arterial diameter will be measured before, during, and after release of the blood pressure cuff.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Cream pudding prepared by a nutritionist to meet the fat composition goals of the study.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include: Those common to venipuncture including bruising and slight risk of infection. Because of the discomfort associated with wearing a blood pressure cuff tightened over 200 mmHg for four to six minutes, subjects are specifically reminded that they can ask to have the cuff removed at any time.
Device A -- Discomfort and the possibility of bruising from the blood pressure cuff; possibility of minor bruising from the tapping device or the frame.
Device B -- Discomfort and the possibility of bruising from the blood pressure cuff and minor irritation from the electrode paste.
PRIVACY/CONFIDENTIALITY/CONSENT
The identities of the subjects are known, but any public report is by code numbers only. The results of the tests are discussed with the subjects. Subjects are reminded that research records are not immune to subpoena and are subject to review by the Food and Drug Administration.
THIS PROTOCOL WAS DISCONTINUED IN OCTOBER 2004.
"Studies of Lipoproteins and Lipid Protein Interactions"
Principal Investigator: Dr. Edward Rubin, Lawrence Berkeley National Laboratory
Project started in: 1977
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 05/19/04
IRB approval number: 2004-5-126
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
OBJECTIVES
Interdisciplinary training program in cellular, molecular, and biophysical aspects of lipid and lipoprotein metabolism and the process of atherogenesis.
METHODOLOGY
Trainees participate in research carried out under other approved protocols. In the past, trainees have utilized blood samples drawn under protocol LBNL-79-106-H02 (Krauss, Ronald: "Metabolic & Genetic Origins of Lipoprotein Subclasses"). No other involvement with human subjects has been reported.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Human subjects involvement in the last few years has been limited to the use of surplus blood collected for another project. No additional risks to subjects are incurred as a result of this grant.
CONFIDENTIALITY
Confidentiality provisions are the same as those of the source protocol. Only samples collected under consent processes that inform subjects that their samples may be used in other research projects may be used in this training grant.
NO POST-DOCTORAL TRAINEES PARTICIPATED IN HUMAN SUBJECTS RESEARCH IN FISCAL YEAR 2004.
"hTERT Reactivation During Immortalization of Human Cells"
Principal Investigator: Dr. Martha R. Stampfer, Lawrence Berkeley National Laboratory
Project started in: 1979
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 03/19/04
IRB approval number: 2004-2-25
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
This research is concerned with the growth control of human breast cells and the relationship of differentiation with transformation.
Human milk contains a small number of living cells that have been sloughed off from the breast tissue during the secretory process. These sloughed cells are isolated from human milk samples and studied to gain an insight into the events taking place within the breast tissue.
Subjects are asked to provide information relating to their general health, age, race, and birth of their child. They express one or more samples of breast milk using their own equipment in the privacy of their home. As subjects are performing this process on a regular basis, no risk directly related to the research is anticipated.
These samples are not collected anonymously. However, when tissue samples or cell cultures are made available to other researchers they are identified only by code number. Subjects are informed as part of the consent process that their samples may be used by others.
No human milk samples were studied by the researcher in FY 2004.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 03/19/04
IRB approval number: 2004-2-25
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The investigator's goal is to determine the morphological, biological, and biochemical properties associated with normal, atypical, and malignant mammary epithelial cells. Such studies will elucidate mechanisms of human carcinogenesis and aid clinicians in the early detection of breast cancer.
The research will use portions of residual tissues from medical procedures such as aspiration of cysts, mammary biopsies, reduction mammoplasty, or mastectomy. Residual tissues from other sites (e.g., skin, cervix) may also be obtained. Samples are identified by patient number and donor location and may be accompanied by medical history data.
Collection of the samples poses no additional risk to the subject. Samples are only obtained from subjects who have given permission for the research use of their tissues. These samples are not collected anonymously, but arrive at the laboratory already identified by code number.
No human samples were studied by the researcher during FY 2004.
"Myocardial Flow, Function, and Metabolism by PET and MRI"
Principal Investigator: Dr. Thomas F. Budinger, Lawrence Berkeley National Laboratory
Project started in: 1980
This project ended in fiscal year 2004.
Funding for Human Subjects Research: No Funding Sources Reported
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 03/05/04
IRB approval number: 2004-3-67
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
TITLE: Evaluation of New Instrument for the Assessment of Vascular Function
OBJECTIVES
The purpose of this study is to compare how well two different devices measure blood flow in the arteries of the arm. The goal is to produce a small, low-cost device that could be used as part of a routine medical check-up to evaluate arterial health.
METHODOLOGY
Up to 30 male and female subjects will be recruited by posting advertisements in local newspapers. Subjects with heart disease, vascular conditions, clotting disorders, hypertension, or a recent venipuncture will be excluded. Each subject will be examined with both the relaxoscope (Device A, the test device) and B-mode/M-mode procedure (Device B, the current standard).
On the day of the study, each subject will receive a brief medical screening. The first 15 subjects will be tested with Device B first, and the second 15 with Device A first. After completion of the first test, subjects will wait about an hour and then be tested with the second device.
Device A procedure: The subject's arm will be positioned in a frame. An artificial pulse will be created by using a mechanical device to gently tap the arm throughout the procedure. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for five to six minutes. The sound of the artificial pulse will be recorded before, during, and for ten minutes after the blood pressure cuff is released using a Doppler stethoscope.
Device B procedure (the current standard): The subject's arm will be positioned in a different frame. Electrocardiogram (EKG) electrodes will be attached. A blood pressure cuff will be applied to the forearm of a subject and tightened to 200 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for about five minutes. Variation of the arterial diameter will be measured before, during and after release of the blood pressure cuff.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
A subset of the subjects will have nitroglycerin or Albuterol administered to stimulate brachial artery dilation. The IRB approved this modification in September 2003.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include:
Device A -- Discomfort and the possibility of bruising from the blood pressure cuff; possibility of minor bruising from the tapping device or the frame.
Device B -- Discomfort and the possibility of bruising from the blood pressure cuff and minor irritation from the electrode paste.
PRIVACY/CONFIDENTIALITY/CONSENT
The identities of the subjects are known, but any public report is by code numbers only. The results of the tests are discussed with the subjects. Subjects are reminded that research records are not immune to subpoena and are subject to review by the Food and Drug Administration.
Because of the discomfort associated with wearing a blood pressure cuff tightened over 200 mmHg for 4 to 6 minutes, subjects are specifically reminded that they can ask to have the cuff removed at any time.
NOTE: The number of subjects participating under this protocol is reported under "Experimental Medicine Clinical" (LBNL 75-001-H02). Additional subjects were not studied under this project, therefore, the number of subjects reported here is zero to prevent counting the same subjects twice. As this parent project is being discontinued, this protocol will only be reported under 75-001-H02 in the future.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 09/23/02
IRB approval number: 2002-10-14
Explanation of IRB approval:
Approval for this protocol ended in August 2003. It was formally discontinued in June 2004.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 09/23/02 to 08/19/03
Explanation:
Final period during which protocol had approval.
Type(s) of Human Subjects Involvement:
TITLE: List Mode Data Acquisition for Clinical PET Studies and Retrospective Gating of Cardiac and Respiratory Motion
OBJECTIVES
The small movements of the chest caused by breathing and the beating of the heart currently degrade the quality of positron emission tomography (PET) images. The purpose of this project is to evaluate the utility of motion compensation in PET studies. The individual subjects will be heart patients who have been prescribed a cardiac PET scan by their personal physicians. Society would benefit from more accurate and economical diagnostic tests.
METHODOLOGY
Subjects will receive a standard PET scan, described below, with one or two rubber bellows placed around the torso to monitor breathing movement.
Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm to inject the radiotracer and to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. First a transmission scan without radiotracer is performed to allow corrections of the emission data. Subjects will then receive one injection of 18F-fluorodeoxyglucose (FDG). Subjects may not move during the scans. The total procedure should take two to two-and-a-half hours.
RADIATION/CHEMICAL SUBSTANCES
18F-fluorodeoxyglucose (FDG)
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); radiation (equivalent to kidney x-ray). There is no increase in risk associated with use of the rubber bellows.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
These PET studies are carried out at the University of California, San Francisco.
THIS PROTOCOL WAS DISCONTINUED IN JUNE 2004.
"Alzheimer's Disease as a Systemic Disorder"
Principal Investigator: Dr. Thomas F. Budinger, Lawrence Berkeley National Laboratory
Project started in: 1984
This project ended in fiscal year 2004.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: RMP 66
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/05/02
IRB approval number: 2002-4-70
Explanation of IRB approval:
Researchers were uncertain whether or not to discontinue this protocol in April 2003. It was finally discontinued in October 2003.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 04/04/02 to 04/04/03
Explanation:
Final period during which the protocol had institutional review board approval.
Type(s) of Human Subjects Involvement:
TITLE: Evaluation of Vascular Reactivity in Alzheimer's Disease via Iontophoresis of Vasoactive Compounds
OBJECTIVES
The goal of this study is to continue to examine the presence or absence of strong correlations between Alzheimer's disease (AD) and peripheral cardiovascular disease. Societal benefits may include a greater understanding of dementing illnesses.
METHODOLOGY
An equal number of control subjects and AD patients will be recruited. Patient subjects are accompanied by an adult family member or guardian to assure an appropriate consent process. AD patients will have been previously evaluated by their treating clinic and these results will be made available to the researchers.
Subjects will fast for 12 hours prior to their study. On the day of the study, subjects will be screened for factors such as the use of aspirin. A small sample of venous blood will be drawn for lipoprotein analysis in order to correlate low density lipoprotein (LDL) levels, reactivity and subject illness. A picture of the blood vessels in the hand will be taken using a laser scanner. The laser is similar in intensity to a laser pointer and is not damaging to the skin.
Areas of the skin will be cleaned using isopropyl alcohol. Small amounts of up to five vasodilators and/or constrictors will be dabbed onto the subject's skin. A one inch square electrode will be placed over the applied chemical, and a tiny electric current applied to cause the chemical to move into localized areas the skin and underlying capillaries. Changes in the circulation will then be non-invasively measured using the same non-invasive laser scanner described above.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
The vasodilators and/or constrictors which may be applied to localized areas of the skin of the arm are sildenafil citrate, nitro-L-arginine methy ester, nitroprusside, methacholine, and acetylcholine. None of the applications will result in a significant or even measurable systemic dose.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Study risks include: venous catheter (bruising, faintness); minor skin irritation or allergic reaction from the chemicals applied to the skin; a slight, transient tingling feeling from the iontophoresis electrode.
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. The results from the venous blood analysis are supplied to the patients' personal physicians upon request. Subjects are reminded that research records are not immune to subpoena. In patients whose cognition is or may be impaired, the consent of the responsible next of kin or conservator as well as the assent of the patient will be sought.
THIS PROTOCOL WAS DISCONTINUED IN OCTOBER 2003.
"National Runners and Walkers Health Study"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 1991
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: Williams 3
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 05/05/04
IRB approval number: 2004-6-38
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 161242
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The objective of this study is to collect self-reported and medical history data as a basis for testing for correlations between various conditions (e.g., lung cancer and heart disease), running activity, and smoking history.
The study hopes to achieve this goal by surveying active exercisers. Questionnaires are distributed to the readers of 'Runner's World' magazine and to participants in current long-distance running events; additional questionnaires were sent to the subscribers of 'Walking' magazine. In total 491,667 questionnaires were mailed in calendar year 2001. Subjects may also be recruited by word of mouth.
The investigator does not contact individuals who do not return an initial survey and consent statement. The survey asks questions about exercise level, diet, weight, and personal habits. Subjects are also asked to sign a release for access to their medical records. If the release is signed, the investigator sends a separate request to the physician's office where the relevant information is abstracted by the physician or his staff and returned to the investigator. These items include results of any recent blood tests for cholesterol and lipoprotein levels.
The subject's participation is limited to completing the survey and allowing access to existing medical records. The only risk to the subject is potential loss of some personal privacy. Results are not collected anonymously and subjects are asked to give the names and contact information for individuals outside the study to aid the researchers in tracking subjects longitudinally. Only aggregate research results, which do not identify individual participants, are published.
No new subjects were recruited in FY 2004.
"Gene Specific Responses to Exercise in Discordant Twins (Formerly, "Effects of Running on HDL and LDL Subclasses of MZ Twins")"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 1992
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: Williams 4
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 09/24/04
IRB approval number: 2003-8-83
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 70
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
This study has two specific aims: to estimate the effects of high level exercise and reduced adiposity on blood lipoprotein apolipoproteins and circulating triglyceride levels and to test whether the effects of adiposity and exercise on lipoprotein concentrations are genotype dependent.
The study utilizes a national survey ("The National Runners Health Study," LBNL-91-107-H01) to identify identical twins with discordant cardiovascular activity levels. The researcher has developed a population of such twins who are willing to participate in the study. Participation consists of completing an additional questionnaire and having blood drawn when the volunteer enters the study and again after two years as a follow-up. Serum samples are obtained by routine venipuncture through either the subject's own physician or through a local lipoprotein screening program. The risks are those common to clinical venipuncture (bruising and the slight chance of infection).
Results are not collected anonymously, and twins will know that their sibling is enrolled in the study. Subjects are also asked to give the names and contact information for individuals outside the study to aid the researchers in tracking subjects longitudinally. Only aggregate research results that do not identify individual participants are published.
The same 35 twin pairs have been studied for the last several years. The researcher has a new source of funding and is seeking to increase his subject population to 200 male and 200 female twin pairs.
No new subjects were recruited for FY 2004.
"National Health Survey on the Internet"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 1998
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: Williams 5
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 03/17/04
IRB approval number: 2004-3-19
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
OBJECTIVE
The objective of this study is to collect self-reported and medical history data as a basis for testing for correlations between various conditions (e.g., lung cancer and heart disease), vigorous exercise, and general health history (e.g., smoking, alcohol consumption).
METHODOLOGY
The researchers have posted an extensive questionnaire on health and life style on the internet. The survey is completed on line, and future follow-ups will also be distributed electronically. An extensive series of interactive features such as construction of a personal food consumption 'pyramid' are available without enrolling in the study. In order for the survey to be forwarded to the researcher's web site, potential subjects must give their age and ask to enroll, complete the entire survey, and respond affirmatively to a second consent statement after completing the study.
The survey asks questions about exercise type and level, diet, weight, health history, and personal habits. Subjects are also asked to print out and sign a release for access to their medical records. If the release is signed, the investigator sends a separate request to the physician's office where the relevant information is abstracted by the physician or the staff and returned to the investigator. These items include results of any recent blood tests for cholesterol and lipoprotein levels.
RISKS/PRIVACY/CONFIDENTIALITY
Minors are excluded from participation in the study. The subject's participation is limited to completing the survey and allowing access to existing medical records. The only risk to the subject is potential loss of some personal privacy. Results are not collected anonymously and subjects are asked to give the names and contact information for individuals outside the study to aid the researchers in tracking subjects longitudinally. Only aggregate research results that do not identify individual participants are published.
OVER 12,000 SUBJECTS HAVE ENROLLED IN THIS STUDY SINCE ITS INITIATION.
During the 2003 to 2004 protocol approval period, there were production problems with the website and no new visitors were enrolled.
"Breast Cancer Specific PET Instrumentation"
Principal Investigator: Dr. William W. Moses, Lawrence Berkeley National Laboratory
Project started in: 1998
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/28/04
IRB approval number: 2003-3-100
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
Abstract:
No protocols have as yet been developed for this project because the positron emission tomography (PET) imaging system is still under development. No human subjects involvement is anticipated before FY 2005. This project was therefore certified to the National Institutes of Health noting that this activity contains multiple projects, some of which have not been approved.
"Effects of Genes on the Relationship of Lifestyle to Disease"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 1999
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: Williams 6
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 01/23/04
IRB approval number: 2002-1-75
Explanation of IRB approval:
This protocol was inactive for some time and was formally discontinued in November of 2003 by the principal investigator.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
OBJECTIVE
Under this protocol the researcher proposes to collect additional data from subjects already participating in the LBNL-91-107-H01 or LBNL-98-107-H06. The objective continues to be collection of self-reported and medical history data as a basis for testing for correlations between various conditions (e.g., lung cancer and heart disease), vigorous exercise, and general health history (e.g., smoking, alcohol consumption).
METHODOLOGY
The study builds on the survey data collection under the two survey projects referenced above. Subjects who have already responded to either the mail or internet survey will be sent a test kit. The test kit will contain a 'safety lancet' and a FTA GeneCard blood collection paper. Subjects will use the lancet to prick their fingers and then blot their fingers on the collection paper. The paper will then be mailed back to the researcher for genetic analysis and archiving.
RISK/CONFIDENTIALITY/CONSENT
The research presents little or no physical risk to subjects; the most significant risk is that of loss of privacy. All subjects are self-selected responders to earlier studies, however, and all information is kept confidential to the maximum extend allowed by law. Results are reported only in the aggregate. Subjects are informed that their samples will be archived for future genetic analysis, and that they will not be provided with their personal results.
AS OF 12/31/01, NO SUBJECTS HAVE BEEN ENROLLED IN THIS STUDY. The study was discontinued in November 2003.
"Training in Mammary Gland Biology and Breast Cancer"
Principal Investigator: Dr. Mina Bissell, Lawrence Berkeley National Laboratory
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 12/03/03
IRB approval number: 2002-11-55
Explanation of IRB approval:
Renewal of this project is pending.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
Abstract:
OBJECTIVE
To provide post-doctoral training opportunities in breast cancer research that focus on molecular biology and cellular microenvironment in mammary gland biology.
In FY2004, only animal research and exempt projects were undertaken by the trainees. Future human subjects research is possible, but is expected to continue to be limited to the use of pre-existing, anonymous human cell lines.
"Novel Functions for Red Cell Proteins Lu and LW"
Principal Investigator: Dr. Joel Chasis, Lawrence Berkeley National Laboratory
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/21/04
IRB approval number: 2004-4-134
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
This project is an extension of the work begun under LBNL-91-068-H03, which was discontinued in fiscal year 2002.
OBJECTIVES
The overall purpose of this study is to develop a detailed understanding of red cell membrane physiology as it relates to red cell function. This study will focus on the contributions of cell membrane erythrocyte adhesion proteins Lu (Lutheran) and LW (Landsteiner Wiener).
METHODOLOGY
Up to ten subjects with Lu or LW red blood cell abnormalities and ten normal controls will be recruited per year. One 5-10 ml of blood will be drawn from each subject for in vitro analysis.
IONIZING RADIATION, RADIOACTIVE OR CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
All the subjects will be in a clinically stable state in which they can safely undergo phlebotomy. Blood is collected by routine clinical venipuncture, which carries with it small risks of bruising or bleeding and the remote risk of infection.
CONFIDENTIALITY
The samples are not anonymous, but only aggregate data are published or reported.
"Estrogen Receptors in the Brain"
Principal Investigator: Dr. Thomas Budinger, Lawrence Berkeley National Laboratory
Project started in: 2001
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: RMP 71
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 08/22/03
IRB approval number: 2003-8-140
Explanation of IRB approval:
This study has been submitted for renewal and approval is pending.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 08/22/03 to 08/21/04
Explanation:
Period for which the study was approved after its 2003 review.
Type(s) of Human Subjects Involvement:
TITLE: Estrogen Receptors (ER) in the Brain
OBJECTIVES
The use of tamoxifen as hormonal chemotherapy in breast cancer is often associated with brain-related side effects such as hot flashes, depression, and cognitive impairment, as well as increased risk of certain other kinds of cancer and cardiovascular disease. The researchers hypothesize that the brain-related side effects are caused by tamoxifen occupying and blocking estrogen receptor subtypes in different areas of the brain. In this study, the distribution of estrogen receptors in the brains of three subject groups will be assessed using a novel radiotracer, fluorine-18 fluoroestradiol, and positron emission tomography (PET).
METHODOLOGY
The researchers will initially study 20 healthy postmenopausal women, 10 already taking estrogen replacement therapy, and 10 not taking any hormones. Researchers will also study 10 postmenopausal women diagnosed with breast cancer and prescribed tamoxifen by their physicians; subjects in this group will be studied before beginning tamoxifen treatment and after 12 months of treatment. All subjects will be under the care of physicians not associated with the study, and no treatment plans will be changed in any way as part of the study. Prior to the scans, a short medical history will be taken to ensure that inclusion/exclusion criteria are met. Subjects will also be given a standard set of neuropsychological tests. Each subject will receive a magnetic resonance imaging (MRI) scan of the brain at the Neuroscience Center of the University of California, Berkeley.
PET studies will be performed at Berkeley Laboratory. Subjects will be offered water to promote urination. A catheter will be placed in a vein in one arm to inject the radiotracer. Subjects are asked to empty their bladder just prior to entering the scanner and just after leaving it to keep the radiation exposure to the bladder as low as possible. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last as long as 120 minutes. For breast cancer subjects, a second scan will be performed 12 months following the initial scan to evaluate changes resulting from tamoxifen therapy.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Internal exposure to the radiotracer Fluorine-18 fluoroestradiol (a Radioactive Drug Research Committee monitored compound). External exposure to radiation during the PET transmission scan.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
PET scan risk includes: venous catheter (bruising, faintness); internal exposure to radiation from the tracer (equivalent to kidney x-ray); external exposure from the transmission scan (equivalent to the amount of background radiation the average person receives in one week).
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
MRI scan risks include: discomfort associated with lying still in an enclosed space.
PET scan risk includes: venous catheter (bruising, faintness); internal exposure to radiation from the tracer(equivalent to kidney x-ray); external exposure to radiation from the transmission scan (equivalent to the amount of background radiation the average person receives in one week).
CONFIDENTIALITY
The identities of the subjects are known, but any public report is by code numbers only. Subjects are reminded that the Food and Drug Administration may have access to their records and that research records are not immune to subpoena.
"Indoor Bioaerosol Detection and Quantification by Polymerase Chain Reaction (PCR)"
Principal Investigator: Mr. William Fisk, Lawrence Berkeley National Laboratory
Project started in: 2001
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 08/11/04
IRB approval number: 2003-8-86
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
CO-INVESTIGATOR: Regine Goth-Goldstein, PhD
OBJECTIVE
This study will develop a quantitative assay for rhinoviruses (the viruses which cause about half of all common colds) and use this assay to characterize the size distribution of droplets produced by the sneezing, etc., of the cold victims. Understanding of the size distribution of airborne rhinovirus may facilitate future development of control measures such as filtration and ventilation.
METHODOLOGY
The first step of the project is the development of an in-vitro polymerase chain reaction (PCR) assay for rhinoviruses. Once the assay is developed, study participants will be recruited to provide test samples for size determination of virus-containing aerosols. Test samples will collected by placing subjects in an office-sized research chamber for three to four hours, while chamber air is sampled with a "multistage inertial impactor" that collects particles in various size ranges. Analysis of these samples by PCR will indicate the size distribution.
IONIZING RADIATION, RADIOACTIVE/CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF HUMAN SUBJECTS
Employees of Berkeley Laboratory will be recruited by posted flyers. Subjects will initially complete a brief survey about their cold symptoms and general health, then produce a mucous sample by sniffing a saline spray, and blowing into a small collection cup.
Subjects will be asked to spend three to four hours in an office-sized research chamber (27 square meters). The room includes a window and is furnished with a desk, computer, television, and a cot. A timed audio record will be made of sneezing/coughing, and continuous samples of aerosols taken. Subjects are free to leave the room at any time.
RISKS
The study is non-invasive and was found to be of minimal risk. Neither an employee's lack of participation nor their decision to participate and subsequent test results will in any way affect their employment status at LBNL.
PRIVACY/CONFIDENTIALITY/CONSENT
Information gathered from this study is not placed in the participant's employee medical file. Because of the length of time needed for the study, subjects are informed as part of the consent process that their supervisor's approval must be obtained. Participants are reminded that co-workers may also learn of their status through simple observation. Only aggregate results without identifiers will be published. Subjects will not be reimbursed directly, but the wage expense incurred during their participation may be billed to the research account.
"Validating Dietary Assessment on the Internet"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 2002
This project ended in fiscal year 2004.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: Williams 7
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 10/25/01
IRB approval number: 2001-8-137
Explanation of IRB approval:
This project was never funded and was discontinued in September of 2004.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
OBJECTIVE
The objective of this study is to validate self-reporting of diet on the internet against traditional food diaries.
METHODOLOGY
Subjects will be selected from those who have already completed the "National Health Survey on the Internet" (LBNL-98-107-H06) and recruited via electronic mail. Half of the 100 subjects will first be requested to record on the internet all food eaten between Monday and Thursday, and then on the following week to record all foods eaten between Monday and Thursday in a food diary. The remaining group of subjects will first complete the diary, then record their intake on the internet. All the diet records will be analyzed by the Diet Assessment Laboratory at the University of Cincinnati.
RISKS/PRIVACY/CONFIDENTIALITY
Minors are excluded from participation in the study. The subject's participation is limited to viewing a video tape of instructions on completing diet records and then completing the internet record and the food diary. The only risk to the subject is potential loss of some personal privacy. Results are not collected anonymously. Subjects are cautioned that their submissions will be reviewed by the Diet Assessment Laboratory, and that the Diet Assessment Laboratory will have subjects' phone numbers and may contact them to clarify points in the food record.
Subjects will be paid $35 for completing the first four-day record and $65 for completing the second four-day record. They will receive a computerized analysis of the diet record submitted on-line.
This project has been discontinued.
"Thermal Comfort of a Task Ventilation System (Formerly, Task Ventilation Optimization)"
Principal Investigator: Dr. William Fisk, Lawrence Berkeley National Laboratory
Project started in: 2002
This project ended in fiscal year 2004.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 08/27/03
IRB approval number: 2003-9-87
Explanation of IRB approval:
Project was discontinued in May of 2004.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 08/27/03 to 05/28/04
Explanation:
Project was discontinued in May of 2004.
Type(s) of Human Subjects Involvement:
CO-INVESTIGATOR: David Faulkner, PhD
OBJECTIVE
Previous work has suggested that increased ventilation rates in office buildings improves worker performance. Because increased ventilation raises energy costs, the objective of this project is to develop a system which minimizes energy costs while improving performance by providing preferential ventilation of an office worker's breathing zone. This study will evaluate the mechanical effectiveness of task ventilation and the thermal comfort experienced by subjects using the system.
METHODOLOGY
Up to 20 LBNL employees will be recruited to participate. All subjects will spend three to four hours working at their normal office duties in an office-sized research chamber utilizing the task ventilation system. Half the subjects will complete up to four thermal comfort questionnaires for different configurations of the ventilation system. The other half will wear a modified telephone headset with an integrated air sampling line and a sample tube on their lapel while minute amounts of an inert tracer gas are injected into the supply air to measure flow. These subjects will complete one comfort survey at the end of their time in the chamber.
IONIZING RADIATION, RADIOACTIVE/CHEMICAL SUBSTANCES
Inert tracer gas sulfur hexafluoride.
RISKS
The study is non-invasive and was found to be of minimal risk. The tracer gas, sulfur hexafluoride, has been used to measure ventilation rates in thousands of buildings with no reported side effects. Neither an employee's lack of participation nor their decision to participate and subsequent test results will in any way affect their employment status at LBNL.
PRIVACY/CONFIDENTIALITY/CONSENT
Information gathered from this study is not placed in the participant's employee medical file. Because of the length of time needed for the study, subjects are informed as part of the consent process that their supervisor's approval must be obtained. Participants are reminded that co-workers may also learn of their status through simple observation. Only aggregate results without identifiers will be published. Subjects will not be reimbursed directly, but the wage expense incurred during their participation may be billed to the research account.
Project was discontinued in May of 2004.
"Chelation Therapy Using Calcium DTPA and/or Zinc DTPA for Internal Contamination with Plutonium and Other Transuranic Elements"
Principal Investigator: Dr. Peter Lichty, Lawrence Berkeley National Laboratory
Project started in: 2002
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 12/01/03
IRB approval number: 2004-6-126
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/20/03
Explanation of additional approval:
This is an additional IRB review, but our own IRB has reviewed and approved this protocol for the current year.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
OBJECTIVES
The purpose of this research is to make chelation therapy with calcium DTPA (diethylenetriamine pentaacetate) available to Berkeley Laboratory employees, guests, students, and contractors who become internally contaminated with plutonium or some other transuranic element. The research will also gather information about the effectiveness and risks of calcium and zinc DTPA.
METHODOLOGY
Only persons accidentally contaminated with plutonium or another transuranic element will be recruited. The dose and treatment schedule will be individually determined for each subject. The level of contamination will be monitored by blood and urine tests.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
Zinc and calcium DTPA (diethylenetriamine pentaacetate). Until recently these two compounds were considered to be investigationsal new drugs. The Investigational New Drug (IND) exemptions for these compounds were numbers 4041 and 14603, respectively, and were held by the Oak Ridge Institute for Science and Education (ORISE). Both compounds are now Food and Drug Administration approved for use in humans.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
No life-threatening toxicity has been associated with the administration of DTPA chelating agents. Among the side effects noted are nausea, vomiting, diarrhea, chills, fever, muscle cramps, and loss of the sense of smell. Usually these symptoms are mild and of short duration and do not persist after a break in the treatment regime. Risks of venipuncture include bruising and a remote risk of infection. The alternative to participation is to not participate and not receive the drug. No other effective treatment is known.
CONFIDENTIALITY
The identities of any subjects will be known to LBNL management and Health Services staff, but any public report will be by code numbers only. Subjects are told that scientists at ORISE and the Food and Drug Administration will have access to their records. Records of contamination and treatment are made available to the subject's personal physician upon request.
To date, this protocol has not been used.
"Undergraduate Training in Mammary Gland Biology and Breast Cancer"
Principal Investigator: Dr. Mina Bissell, Lawrence Berkeley National Laboratory
Project started in: 2003
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 06/25/04
IRB approval number: 2004-6-55
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
Abstract:
OBJECTIVE
To provide advanced training opportunities to undergraduate students in breast cancer research that focus on molecular biology and cellular microenvironment in mammary gland biology.
In FY2004 only animal research and exempt projects were undertaken by the trainees. Future human subjects research is possible but is expected to continue to be limited to the use of pre-existing, anonymous human cell lines.
"Nu 99G8: The National Ovarian Cancer Early Detection Program - Molecular Cytogenetic Detection of Early Cancer"
Principal Investigator: Dr. Joe W. Gray, Lawrence Berkeley National Laboratory
Project started in: 2003
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 09/30/04
IRB approval number: 2004-2-13
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Northwestern University
Most recent approval: 12/12/03
IRB approval number: 0201-004
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
OBJECTIVES
To use comparative genomic techniques to develop improved methods for early cancer detection, particularly in women at risk for development of ovarian cancer.
METHODOLOGY
Residual tissue samples and patient record data are collected at Northwestern University under their fully-approved protocol. The samples are coded before being sent to Berkeley Laboratory for array comparative genomic hybridization and/or fluorescence in situ hybridization with gene-specific probes.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Berkeley Laboratory receives anonymous tissue samples and some limited data for analysis. The samples are residual from those normally taken from patients undergoing initial surgical evaluation or biopsy for purposes of their own treatment. No additional risks to subjects are incurred as a result of this project.
CONFIDENTIALITY
Samples are received at Berkeley Laboratory already coded, and Berkeley Laboratory has no access to the code key. Subjects are informed as part of the consent process at Northwestern that their samples may be used in other research projects.
"Improved Cardiac SPECT with Convergent Hole Collimators"
Principal Investigator: Dr. Grant T. Gullberg, Lawrence Berkeley National Laboratory
Project started in: 2003
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.