Ms. Kayleen Christie
St. Mary's Hospital Public Relations Department
PO Box 1628
Grand Junction, CO 81502-1628
Phone: 970-244-2000
Fax: 970-244-2902
Email: Kchristie@stmarygj.com
Projects are approved by an IRB located at: St. Mary's Hospital Saccomanno Research Institute.
The approving IRB does not operate under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
Number of Human Subjects Projects reported: 2
Project Identifier: SMHSRI-95-DE-FG03-95ER62060/A0
Project Title:
Identification of Human Lung Cancer Susceptibility Genes (See SMHCRI-95-DE-FG03-95ER62060/A0 in FY96 database)
Principal Investigator:
Dr. Eugene D. Carstea
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
1/1/97 - 12/30/97; This grant's budget period goes from 5/5/97 to 2/28/98
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 19, 1996
IRB Approval Number: 9600013
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 100
Type of Human Subjects Involvement:
A. Objective: The contribution of tobacco smoke products to the development of lung associated tumors has long been investigated. Recent studies have proven that a highly carcinogenic chemical component of cigarette smoke, benzo(a)pyrene, interacts with the nuclear DNA of respiratory epithelial cells resulting in mutations of the p53 tumor suppressor gene, contributing to lung carcinogenesis. It is also becoming increasingly apparent that members of certain cancer-prone families have an increased risk for developing lung cancer that is greater than that of the overall population living under relatively similar environmental conditions. This would suggest an inherited (genetic) component. The primary objectives of this project are to: 1) generate pedigrees for lung cancer susceptible families and collect tissue samples (healthy and/or tumor) from family members for molecular genetic assessments; 2) identify regions likely to contain lung cancer susceptibility genes as determined by: a) genotype/linkage analysis, and b) LOH assessments on appropriate tissues from individual families; and 3) begin to identify candidate genes within defined chromosomal intervals. The long-term goal is to characterize these "cancer causing" genes and to determine the role that this mutant gene plays in tumorigenesis. This information could lead to early lung cancer diagnosis and more effective therapies.
B. Methodology: Families chosen for this study include approximately equal numbers of both sexes from patient populations reflecting the ethnic and racial components of the areas served by St. Mary’s Hospital & Medical Center, as well as families referred to the study from outside this catchment area. Comprehensive pedigrees and information on smoking, occupational and environmental exposures will be compiled for families with extensive histories of pulmonary neoplasm. Study families will be given a complete explanation of the project, the risks and benefits, as well as our expectations in regards to the availability of health related information and biological samples. For family members outside the catchment area, this interview will be conducted by phone with a follow up detailed project description and informed consent sent by certified mail. Arrangements will be made for blood samples to be drawn by medical professionals both locally and for distant subjects. Study families will be analyzed using Polymerase Chain Reaction (PCR) based primers to determine the lengths of simple sequence repeats and genetic segregation, and linkage analysis will be performed to locate a susceptibility locus.
C. At no time are these subjects either intentionally or unintentionally exposed to any of the following substances: ionizing radiation, radioactive substances, or any other chemical substance.
D. Involvement of Human Subjects: The families will be selected based on the following criteria:
1. Male or female relatives (by blood or marriage) or a proband with a tissue confirmed primary lung carcinoma. These include, but are not limited to, siblings, offspring, parents, grandparents, aunts, uncles and cousins.
2. Study subjects will be asked to sign an informed consent to participate in the study. Also they will be requested to sign a medical release for information/specimen acquisition.
3. 20 - 40 ml. of venous blood from each participating living family member.
The risks associated with venipuncture draw include possibility of discomfort at the needle sight, slight bleeding, fainting, risk of bruise and infection. Patients will be given instructions on the care of the venipuncture site, and immediate necessary short-term medical care will be provided without cost to the subject. There is a possibility that participation in this study may make subjects feel emotionally uncomfortable as talking about family health problems may be difficult.
We will not release any information about any study patient without written permission. This includes other family members, insurance company or employer. Subjects are informed that some isolated instances are know where information about an individual’s participation in such a research study have been obtained by third parties and has affected their ability to obtain insurance. Access to any medical records and/or stored samples by the researchers are for research purpose only and are maintained according to current legal requirements, and may be made available for review, if required by the FDA or other authorized users, but only under the guidelines established by the Federal Privacy Act. No patient identifiable information will be used in any presentation or published study.
Patients are explained the consent process including methods, inconveniences, risks, benefits, and are given time for any questions prior to the signing of the Informed Consent Document. They are informed that they are being invited to voluntarily participate in the study and that they are free to withdraw at anytime without incurring ill will or any possibility that their withdrawal will affect their future medical care.
Project Identifier: SMHSRI-97-DE-FG02-90E60939
Project Title:
Early Lung Cancer Detection in Uranium Miners with Abnormal Sputum Cytology (See SMHCRI-97-DE-FG02-90E60939 in FY96 database)
Principal Investigator:
Dr. Geno Saccomanno
Project started in: 1997
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 25, 1997
IRB Approval Number: pending revision
Number of Human Subjects who participated in this project/protocol during
07/01/96 - 04/30/97: 270
Type of Human Subjects Involvement:
A. Objectives: The primary objectives of this project are to identify underground uranium miner's who are at high risk for the development of lung cancer by monitoring sputum cytologic samples from these individuals for morphological changes consistent with a neoplastic process, and to continue to collect epidemiological data for inclusion in the Saccomanno Uranium Workers Archive.
B. Methodology: Cytologic surveillance continues on a group of 270 uranium miners who show abnormal cells in their sputum samples. Sputum collection kits are sent to this study group on a routine basis as determined by their accession numbers, corresponding to a confidential miner identification source. The samples are processed and evaluated using current state-of-the-art laboratory procedures. The final diagnosis is communicated to the subjects' primary care physicians for appropriate follow-up measures. Once a diagnosis of primary bronchogenic carcinoma has been confirmed, either cytologically or pathologically, the subject is entered in the tumor registry under a non-identifying number. All cytologic and histologic specimens are archived, as well as subject demographics, clinical and ancillary reports, and subject consent forms.
C. At no time are these subjects either intentionally or unintentionally exposed to any of the following substances: ionizing radiation, radioactive substances, or any other chemical substance.
D. Involvement of Human Subjects:
1. The study subjects are referred by their attending physicians, other enrolled subjects, or by self-referral. Once the initial inquiry is made by the miner or the miner's physician, an information packet detailing the study is given to the potential subject. This usually follows extensive dialogue with the miner which includes information regarding eligibility and project protocols. The IRB approved subject consent form is included in the packet. After the subject has returned the signed, written consent form, he/she receives a sputum specimen container kit that includes instructions for obtaining an optimal sample by spitting any material coughed up from deep in the lungs into a bottle. Upon return of the sample to the laboratory, it is processed, evaluated, and a diagnosis is given. The results are communicated to the attending physician. As with other laboratory tests, appropriate follow-up is the responsibility of the physician. None of the above stated procedures require involvement with the subject in any way other than which is acceptable in a routine sputum cytologic examination for clinical medical monitoring.
The risk, as defined in the Definition Section ruling of the OPRR Reports Protection of Human Subjects, Title 45, Code of Federal Regulations, Part 46 - Protection of Human Subjects - Section 46.102, part (i) "..., is minimal meaning the probability and magnitude of harm or discomfort anticipated in research (the acquisition of a sputum sample) are not greater in and of themselves then those ordinarily encountered in daily life or during the performance of a routine physical...examination..." (e.g., routine coughing up of mucus material and spitting it into a handkerchief or tissue to clear airways).
2. The Balance of Risks to Potential Benefits:
The risks are felt to be minimal, and, thus, the potential benefits are felt to far outweigh the possible risk factor. The benefits, as stated in the research proposal are as follows:
a. Research will continue to provide a vast amount of invaluable data and material for epidemiological studies.
b. In following these cellular changes that identify the probable progression to lung cancer, it is possible to diagnosis occult lung cancer at a stage when it is curable.
c. To help develop laboratory tests that may lead to a better understanding of lung cancer, its causes, and hopefully earlier detection.