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: 52
| LBNL-75-001-H02 | "Experimental Medicine Clinical" |
| LBNL-77-057-H02 | "Studies of Lipoproteins and Lipid Protein Interactions" |
| LBNL-79-108-H01 | "Culture and Characterization of Human Mammary Cells (Note: formerly hTERT Reactivation During Immortalization of Human Cells)" |
| 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-96-250H02 | "Age Effects On the Incidence of Genetic and Physiological Defects in Human Sperm" |
| LBNL-98-107-H06 | "National Health Survey on the Internet" |
| LBNL-98-139-H01 | "Breast Cancer Specific PET Instrumentation" |
| LBNL-00-143-H01 | "Novel Functions for Red Cell Proteins Lu and LW" |
| 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-04-189H01 | "Classroom HVAC: Improving Ventilation and Saving Energy" |
| LBNL-04-250H01 | "Effects of Occupational Benzene Exposure in Human Sperm: A Study of Chinese Factory Workers" |
| LBNL-04-73H01 | "Brain Imaging with [F18]-Fluorodeoxyglucose (FDG) in Adult Males and Females-New Methods for Analyzing PET Data" |
| LBNL-04-85H01 | "Brain Imaging with [F-18]-Fluorometatyrosine in Adult Males and Females: Implications for Parkinson's Disease" |
| LBNL-05-130H04 | "SPORE Ovarian Cancer: Markers for Assessment for Response to Therapy" |
| LBNL-05-161H08 | "Human DNA Resequencing: Absence of the Corpus Callosum" |
| LBNL-05-161H10 | "Human DNA Re-Sequencing: Greenwood Genetic Center Samples" |
| LBNL-05-180H04 | "Low-Field Magnetic Resonance Imaging of the Wrist and Arm" |
| LBNL-05-189H03 | "Simple Exposure Indicators for ETS Particles" |
| LBNL-05-194H03 | "Identification of Common Contaminents in Latent Fingerprints" |
| LBNL-05-208H03 | "Culture-Independent Microbial Study of Endotracheal Aspirates from Intubated Patients" |
| LBNL-05-226H01 | "Comparison of Helium Ion and Proton Therapy Techniques for Treatment of Uveal Melanoma" |
| LBNL-05-243H01 | "Culture-Independent Identification and Characterization of Microbial Community Associated with Bacterial Vaginosis" |
| LBNL-05-34H07 | "Resequencing of Candidate Genes from Patients with Brain Malformations" |
| LBNL-05-73H02 | "Dopamine Metabolism Imaging and Cognition in Aging" |
| LBNL-05-73H03 | "Amyloid Imaging in Aging, Cognitive Decline, and Dementia" |
| LBNL-05-73H04 | "Berkeley Aging Cohort Study" |
| LBNL-05-85H05 | "A Phase I Open-Label Safety Study of Intrastriatal Infusion of Adeno-Associated Virus Encoding Human Aromatic L-Amino Acid Decarboxylase (AAV-hAADC-2) in Subjects with Advanced Parkinson's" |
| LBNL-06-107H10 | "Cholesterol and Pharmacogenetic Study" |
| LBNL-06-130H05 | "SPORE Breast Cancer: Genomic and Biological Analyses of Human Breast Tumors" |
| LBNL-06-161H12 | "Human DNA Re-Sequencing: Clinical Investigaton of Patients with Chromosome Aberrations" |
| LBNL-06-161H13 | ""Human DNA Re-Sequencing: Dallas Heart Study Samples"" |
| LBNL-06-161H14 | "Human DNA Re-Sequencing: UCSF Obesity Samples" |
| LBNL-06-161H15 | "Human DNA Re-Sequencing: Circadian Rhythm Samples" |
| LBNL-06-161H16 | "Human DNA Re-Sequencing: Noonan Syndrome" |
| LBNL-06-180H06 | "Low-Field Magnetic Resonance Imaging of the Brain" |
| LBNL-06-251H01 | "LBNL Climate Survey" |
| LBNL-06-73H05 | "Dopamine Metabolism Imaging and Cognition in Young Adult Subjects" |
| LBNL-06-87H01 | "Effects of Chemotherapy on Brain Structure and Function" |
"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: 7
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 12/05/05
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. Berkeley Lab procedures are to be applied twice, once during the initial visit, then two to four months following the 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), and 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 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.
UPDATE: This study will be discontinued in FY2007.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 06/29/06
IRB approval number: 2004-6-127
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: 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 and 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. Test results are discussed with the subjects. Subjects are reminded that research records are not immune to subpoena.
UPDATE: This study was inactive in FY2006.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 12/05/05
IRB approval number: 2004-8-51
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: Temporomandibular Joint Disease and Metabolism of Muscles of Mastication: PET Imaging
OBJECTIVES
The researchers hypothesize that temporomandibular joint (TMJ) disease may be caused by fatigue due to excessive pressure on the jaw by the surrounding muscles. The aim of this research is examine the positron emission tomography (PET)-fluorodeoxyglucose (FDG-18) modality as a means to more accurately diagnose and monitor the efficacy of therapy for TMJ disease.
METHODOLOGY
Up to 25 TMJ patients between the ages of 18 to 75 will be recruited from the Temporomandibular Disease/Orofacial Pain Clinic at the University of California at San Francisco (UCSF). Potential subjects are recruited by clinic staff and those who agree will have their contact information forwarded to the Berkeley Lab. Subjects will be given an in-depth screening, including a pregnancy test for women, after formally consenting to the research. Each subject will undergo one PET scan of the head and jaw muscles at rest.
PET Scan Procedure: 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 as possible. 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 and faintness), internal radiation (equivalent to three years of natural background radiation or an x-ray computed tomograph of the abdomen), and external radiation exposure from the transmission scan (equivalent to the amount of background radiation the average person receives in one week).
CONFIDENTIALITY
Subjects will be asked to sign a Health Insurance Portability and Accountability Act (HIPAA) research authorization to allow the researchers access to their TNJ-related medical information. 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 research records are not immune to subpoena.
UPDATE: This study have been inactive this past year.
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
Explanation of IRB approval:
Researchers are considering whether or not to discontinue this study.
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: 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. The researchers hypothesize that temporomandibular joint (TMJ) disease may be caused by fatigue due to excessive pressure on the jaw by the surrounding muscles. While there is no direct benefit to the subjects, society as a whole may benefit from an improved technique for the diagnosis and management of temporomandibular joint 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 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 as possible. 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 risks include: venous catheter (bruising and faintness), internal radiation exposure (equivalent to nine years of natural background radiation or an x-ray computed tomograph of the abdomen), and external exposure from the transmission scan (equivalent to the amount of background radiation the average person receives in one week). 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 proceed 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 scans 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.
UPDATE: This study may be discontinued soon.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 01/27/06
IRB approval number: 2004-3-67
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 14
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
Co-Investigator: Jonathan Maltz, PhD
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 80 male and 80 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 (Procedure A, the test device) and B-mode/M-mode procedure (Procedure B, the current standard). Subjects may also be asked to return to take part in Procedures C, D, E and/or F.
On the day of the first study, each subject will receive a brief medical screening. Half of the subjects will be tested using Procedure A first, and the second half with Procedure B first. After completion of the first test, subjects will wait about an hour and then be tested with the second device.
Procedure A: 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.
Procedure B (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.
Procedure C uses the same device and protocol as A, but subjects are given either a single tablet of nitroglycerin or a dose of albuterol as a vasodilator. The procedure is performed twice, once before and once after administration of the vasodilator.
Procedure D uses the same device and protocol as B, but subjects are given either a single tablet of nitroglycerin or a dose of albuterol as a vasodilator. The procedure is performed twice, once before and once after administration of the vasodilator.
An option of sampling venous blood has been added and approved by the institutional review board.
Procedure E: The subject's arms are both positioned at rest on a tabletop. A blood pressure cuff will be applied to one arm, and the subject's blood pressure will be taken. Temperature sensors will be secured to each of the subject's hands. The cuff is then tightened to 200 to 220 mmHg (slightly tighter than used for normal blood pressure measurements) for about five minutes. The temperature of the hands will be measured before, during, and after release of the blood pressure cuff.
Procedure F: The subject's arms are both positioned at rest on a tabletop. A blood pressure cuff will be applied to one arm, and the subject's blood pressure will be taken. Temperature sensors will be secured to each of the subject's hands. The temperature of the subject's hands will then be recorded for 5 minutes. Subjects will then be given a single dose of either nitroglycerin or albuterol, and the temperature of their hands will be measured for a further 10 minutes. The procedure will conclude with a second blood pressure measurement.
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES
A single dose of nitroglycerin or albuterol will be administered as part of Procedures C, D, and F; both of these pharmaceuticals are approved by the Food and Drug Administration.
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.
Administration of nitroglycerin or albuterol may cause dizziness, headache, lightheadedness, or flushing. Subjects are encouraged to sit or stand up slowly after receiving either compound. In the case of severe headache, acetominophen will be offered as a pain reliever.
The risks of a small blood draw include the discomfort of needle insertion, the chance of bruising, or, very rarely, infection.
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: 04/22/05
IRB approval number: 2004-3-56
Explanation of IRB approval:
This protocol was discontinued on 2/9/2006.
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: 10/01/05 to 02/09/06
Explanation:
This protocol was discontinued on 2/9/2006.
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), and 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 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.
This protocol was discontinued on 2/9/2006.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 04/10/06
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), and 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 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.
UPDATE: This study has been inactive for the past year but could start up again in 2007.
"Studies of Lipoproteins and Lipid Protein Interactions"
Principal Investigator: Dr. Edward Rubin, Lawrence Berkeley National Laboratory
Project started in: 1977
This project ended in fiscal year 2006.
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: 06/08/05
IRB approval number: 2004-5-126
Explanation of IRB approval:
This protocol was discontinued in March 2006.
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.
UPDATE: This protocol was discontinued in March 2006.
"Culture and Characterization of Human Mammary Cells (Note: formerly 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: 03/28/06
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 collected by the researcher in FY2006.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Lawrence Berkeley National Laboratory
Most recent approval: 03/28/06
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 and 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 new samples were received by the researcher during FY2006.
"National Runners and Walkers Health Study"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 1991
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: 05/05/06
IRB approval number: 2004-6-38
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 42916
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 FY2006.
"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: 10/07/05
IRB approval number: 2003-8-83
Explanation of IRB approval:
Renewal is currently pending.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 249
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: (1) to estimate the effects of high level exercise and reduced adiposity on blood lipoprotein apolipoproteins and circulating triglyceride levels and (2) 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 subject pool was previously set at 66 twin pairs. The researcher has requested and received approval to increase his subject population to 200 male and 200 female twin pairs.
"Age Effects On the Incidence of Genetic and Physiological Defects in Human Sperm"
Principal Investigator: Dr. Andrew Wyrobek, Lawrence Berkeley National Laboratory
Project started in: 1996
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: 09/22/06
IRB approval number: 2003-8-151
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-INVESTIGATORS: Dr. Brenda Eskenazi, University of California at Berkeley
Although it is well accepted that maternal age can result in adverse consequences to the fetus, it remains unclear whether paternal age also influences fetal viability and pregnancy outcome. Evidence for male-mediated developmental toxicity derives from strong animal data that premating paternal exposures can lead to adverse developmental effects. In addition, there is growing epidemiological evidence that exposures of fathers to environmental toxicants are associated with adverse consequences to the fetus. However, the underlying mechanism for the effects of paternal exposure remain unresolved and is likely to include genetic defects transmitted by sperm.
The hypotheses for this study are to: (1) determine whether there is an effect of a man's age on the types and proportions of genetic damage in sperm measured by various methods and semen quality and (2) examine whether certain diets are associated with higher rates of genetic damage and decreased semen quality.
This research will provide fundamental information on the effects of paternal age and diet on genetic damage to human sperm. These findings will also provide critical data needed for the design and interpretation of studies of paternal effects of exposure to environmental agents.
METHODOLOGY/PROCEDURES
The recruitment phase is completed, the specimens are under laboratory analyses, and the resulting data are in statistical analyses. The study population was comprised of healthy male volunteers employed at or retired from Lawrence Livermore National Laboratory. Potential participants with known fertility problems and/or who smoked were excluded. The total study population of 85 was stratified by age: 20 aged 20 to 29 years, 15 aged 30 to 39 years, 15 aged 40 to 49 years, 15 aged 50 to 59 years, and 20 aged 60 or over.
Subjects were asked to complete a questionnaire, a radiation dosimetry history, and a food frequency diary. Subjects also provided a single sperm sample.
The following laboratory analyses were performed: sperm concentration, visual motility, and computer assisted sperm analysis (CASA) motility; nuclear morphometry assay; sperm chromatin assay, sperm chromosomal aneuploidy, and aberration assay. The following analyses are in progress or will be conducted next year: mutation frequency at various specific genes and micronutrient analyses.
RADIOACTIVE/CHEMICAL SUBSTANCES
None.
RISKS
Some subjects may find it physiologically or psychologically difficult to provide a sperm sample.
CONSENT/CONFIDENTIALITY/PRIVACY
Potential participants were screened by phone. Subjects provided a signed consent form along with their sperm sample. Questionnaires were filled out only after the consent form and sperm sample were provided. All samples and data were coded, and code key was kept in locked location separate from the actual data.
There are no further procedures involving direct contact with human subjects. Further activity is limited to the analyses of archived samples.
This study was previously listed in the DOE Human Subjects Research Database as Lawrence Livermore National Laboratory Project LLNL-96-109.
"National Health Survey on the Internet"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 1998
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: 03/06/06
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 and 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. Researcher is currently seeking funding to continue the project.
"Breast Cancer Specific PET Instrumentation"
Principal Investigator: Dr. William W. Moses, Lawrence Berkeley National Laboratory
Project started in: 1998
This project ended in fiscal year 2006.
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: 04/20/05
IRB approval number: 2004-5-138
Explanation of IRB approval:
This protocol was discontinued in February 2006.
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 FY2006. 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.
UPDATE: This protocol was discontinued in February 2006.
"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: 05/11/06
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 to 10 ml blood draw will be obtained 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 to be used are not anonymous, but only aggregate data will be published or reported.
"Advanced Techniques in Latent Fingerprint Detection, Visualization and Analysis"
Principal Investigator: Dr. Michael C. Martin, Lawrence Berkeley National Laboratory
Project started in: 2003
This project ended in fiscal year 2006.
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: 08/11/05
IRB approval number: 2003-8-9
Explanation of IRB approval:
This study expired on 8/10/2006 and the researcher has decided not to renew.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
CO-INVESTIGATORS: Wayne McKinney, PhD; Dale Perry, PhD; and T.J. Wilkinson
OBJECTIVE
To investigate the chemical nature of human latent fingerprints deposited by pre-pubescent and pubescent children as well as adults. The researchers hope to develop methods of latent fingerprint anlysis which will allow both the identification of latent prints from pre-pubescent children and some characterization of the fingerprint's depositor such as gender.
METHODOLOGY
Approximately 120 subjects will be recruited in three groups: adults, pubescent children (13 to 18 of age), and prepubescent children (under 13). Subjects will be recruited from among the Berkeley Lab staff and from private schools in the Berkeley area.
Subjects will be asked their age, gender, and whether or not they are taking any over-the-counter or prescription medications. Subjects will then be asked to give two latent fingerprints on gold or silver coated media after running their fingertips across their forehead, neck, or arm.
IONIZING RADIATION, RADIOACTIVE/CHEMICAL SUBSTANCES
None.
RISKS
The study is non-invasive and was found to be of minimal risk.
PRIVACY/CONFIDENTIALITY/CONSENT
Participation in the research may involve a slight risk of loss of confidentiality. However, all identities are treated as confidential. Names will never be associated with the fingerprint samples; the subjects' names will appear only on the consent forms. Fingerprints and data are labeled only with a randomly generated identification number, which is not linked to the list of names. After testing is complete, even the consent forms will be destroyed. Berkeley Lab participants are reminded that co-workers may learn of their status through simple observation.
UPDATE: This study has ended.
"Advancing Electrochromic Windows"
Principal Investigator: Mr. Stephen Selkowitz, Lawrence Berkeley National Laboratory
Project started in: 2003
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: 08/11/05
IRB approval number: 2003-9-51
Explanation of IRB approval:
Researchers are currently considering whether or not to discontinue this protocol.
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: Eleanor Lee
OBJECTIVE
The overall objective of this study is to assess the energy use and occupant comfort associated with a new energy efficiency technology, electrochemical windows. Electrochromic windows dim from a clear to dark transparent blue with the turn of a knob. User satisfaction, the need for accessory light control with blinds, energy use, and control algorithms will be assessed.
METHODOLOGY
Up to 110 subjects will be recruited to participate. Subjects will be recruited from among Berkeley Lab employees and students and employees of the University of California, Berkeley campus. All subjects will spend three to four hours working at their normal office duties in an office-sized research chamber utilizing electrochromic windows. Each mode of control will be used for about an hour, after which subjects will complete a user questionnaire.
IONIZING RADIATION, RADIOACTIVE/CHEMICAL SUBSTANCES
None.
RISKS
The study is non-invasive and was found to be of minimal risk.
PRIVACY/CONFIDENTIALITY/CONSENT
Information gathered from this study does not become part of the participant employee's medical or personnel files. Because of the length of time needed for the study, those subjects who are Berkeley Lab employees 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 either the wage expense incurred during their participation may be billed to the research account or they may receive a voucher for a meal at a local restaurant.
Researchers are currently still analyzing data from 43 human subjects studied from 2003 to 2004. They will probably no longer recruit subjects in the future. This protocol may be discontinued soon.
UPDATE: Researchers are currently deciding on whether or not to discontinue this project.
"Evaluation of Iodorotenone, a SPECT Perfusion Tracer"
Principal Investigator: Dr. Henry VanBrocklin, 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: 09/21/05
IRB approval number: 2004-3-33
Explanation of IRB approval:
Renewal 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:
The objective of this study is the development of new iodine-based radiotracers for single photon emission computed tomography (SPECT) imaging. Although the goals of the research include testing the tracers in human subjects, no specific protocols to date have been developed.
Researchers are still in the pretest phase for the compound.
"Role of CYP1B1 in PAH-DNA Adduct Formation and Breast Cancer"
Principal Investigator: Dr. Regine Goth-Goldstein, Lawrence Berkeley National Laboratory
Project started in: 2003
This is an international project.
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: 09/01/06
IRB approval number: 2003-8-148
Additional IRB approvals from other institutions:
Type of Review:
Full Board
Approving Institution: University of California at Berkeley
Most recent approval: 09/01/06
IRB approval number: FWA00003706
Explanation of additional approval:
Collaborating Brazilian institution (Hospital Moinhos de Vento) has an assurance of compliance, FWA00003706, with the University of California at Berkeley IRB. This assurance was recently renewed and now has an expiration date of 6/30/2009. The project was reviewed by the Brazilian National Ethnics Board (CONEP) before initial approval.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 27
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
OBJECTIVES
The objective of this study is to test hypotheses regarding the relationships between breast cancer, exposure to environmental contaminants, and genetic factors involved in the metabolism of these chemicals.
METHODOLOGY
Subjects will be recruited from female patients 30 to 69 in age who present themselves for breast lump biopsy, mastectomy, or breast reduction surgery in Rio Grande do Sul, Brazil. Patients who elect to participate will be given extensive health history and chemical exposure interviews prior to their surgery. At the time of the surgery, an additional 7 ml blood sample will be drawn for research purposes, and small amounts of breast fat and epithelial cells will be separated from the surgically-obtained tissues. No additional tissue will be removed for the purpose of research. The tissue and serum samples will be sent with the interview data to Berkeley Lab for analysis.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
No additional physical risk will be added by a patient's participation in the research study. Discomfort or distress may be experienced by the subjects while responding to personal questions; participants will be assured that they may skip any question or discontinue participation at any time.
CONFIDENTIALITY
The samples from Brazil will not be anonymous to the Berkeley Lab investigators. The study materials and the identification keys for study participants will be kept locked in separate locations. Data are reported only in the aggregate.
UPDATE: This study was modified in 2006 to enable analysis of additional tissues.
"Long-Term Exercise Maintenance via Internet Support"
Principal Investigator: Dr. Paul T. Williams, Lawrence Berkeley National Laboratory
Project started in: 2004
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: 11/19/05
IRB approval number: 2003-10-96
Explanation of IRB approval:
Renewal in November is currently pending.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 30075
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
OBJECTIVES
This research will examine whether on-line information and interactive tools can effectively promote running and walking.
METHODOLOGY
Subjects will be recruited from the National Runners Health Study (107H05). They will be randomly sorted into groups which receive either references to websites about running, or access to information and interactive tools developed by the researcher to promote running and walking.
IONIZING RADIATION, RADIOACTIVE SUBSTANCE, CHEMICAL SUBSTANCES
None.
INVOLVEMENT OF HUMAN SUBJECTS
The survey procedures used in this study are identical to those in the previously approved "National Runners Health Study" (107H05) and the "National Health Survey on the Internet" (107H09).
The investigator does not contact individuals who do not return an initial paper survey and consent statement. The surveys ask questions about exercise level, diet, weight, and personal habits. Subjects are also asked to sign a release for access to their medical records, although this is not a requirement for participation. 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 paper and on-line surveys 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.
"The Biology of Ovarian Cancer: Genome Evolution and Gene Discovery in Ovarian Cancer"
Principal Investigator: Dr. Joe W. Gray, Lawrence Berkeley National Laboratory
Project started in: 2004
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: 07/24/06
IRB approval number: 2004-6-240
Additional IRB approvals from other institutions:
Type of Review:
Expedited
Approving Institution: University of British Columbia
Most recent approval: 01/05/06
IRB approval number: R04-0102
Explanation of additional approval:
Review and approval at the University of British Columbia preceded our review and approval for renewal by six months.
Type of Review:
Full Board
Approving Institution: University of California San Francisco
Most recent approval: 03/15/06
IRB approval number: H7810-09827-14A
Explanation of additional approval:
Review and approval at University of California at San Francisco preceded our review and approval for renewal by three months.
Type of Review:
Full Board
Approving Institution: University of Texas M.D. Anderson Cancer Center
Most recent approval: 04/06/06
IRB approval number: LAB01-037
Explanation of additional approval:
Review and approval at University of Texas preceded our review and approval for renewal by two months.
Type of Review:
Full Board
Approving Institution: University of Texas M.D. Anderson Cancer Center
Most recent approval: 01/04/06
IRB approval number: GOG8004
Explanation of additional approval:
Review and approval at University of Texas preceded our review and approval for renewal by six months.
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 elucidate the genomic and biological changes in ovarian cancers that contribute to tumor progression and/or response to therapy.
METHODOLOGY
Collaborations have been established with ovarian tissue repository banks at the University of California at San Francisco (UCSF), the University of British Columbia, and the University of Texas M.D. Anderson Cancer Center. The banks are regulated by protocols approved by the institutional review boards at these institutions as noted above. The samples are coded before being sent to Berkeley Lab for array comparative genomic hybridization and/or fluorescence in situ hybridization with gene-specific probes.
INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS
Berkeley Lab 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.
Because no subjects are recruited or participate at Berkeley Lab, the number of subjects reported above is entered as zero.
CONFIDENTIALITY
Samples are received at Berkeley Lab already coded, and Berkeley Lab has no access to the code keys. Subjects are informed as part of the consent process at the collecting institutions that their samples may be used in other research projects. Subjects are also told that they will not receive any information relevant to their care or condition from their participation in this research.
UPDATE: The University British Columbia was added in 2006 as a source of tissue samples. Approximately 1,000 samples were received at Berkeley Lab in fiscal year 2006.
"Human DNA Re-Sequencing: Slavotinek Samples"
Principal Investigator: Dr. Len A. Pennacchio, Lawrence Berkeley National Laboratory
Project started in: 2004
Funding for Human Su