Ms. Kayleen Christie
St. Mary's Hospital Public Relations Department
PO Box 1628
Grand Junction, CO 81502-1628
Phone: 970-244-2000
Fax: 970-244-2891
Projects are approved by an IRB located at: St. Mary's Hospital Cancer 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: 3
Project Identifier: SMHCRI-94-DE-FG03-94ER61842
Project Title:
Examination of Genetic Alterations in Preneoplastic Lesions of the Lung from Uramium Miners
Principal Investigator:
Dr. Marshall Anderson
Project started in: 1994
This project ended in Fiscal Year 1996.
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: November 01, 1995
IRB Approval Number: 95-0007
Number of Human Subjects who participated in this project/protocol during
04/01/95 - 03/31/96: 111
Type of Human Subjects Involvement:
A. Objective: The main objective of this study is the morphological diagnosis of early lung cancer lesions. Current studies at St. Mary's Hospital reveal improved survival utilizing sputum cytology, while national statistics for early detection fail to duplicate this finding. This study will attempt to better understand lung tumorigenesis in uranium miners by molecular analysis of gene alterations in both preneoplastic lesions and malignant neoplasms to ascertain the stage of tumor development at which protooncogenes and tumor suppressor genes are mutated/lost. Three long term goals of this study are
1) to detect early genetic and/or cellular alterations which ultimately could
lead to diagnostic modalities for the early detection of lung cancer.
2) to determine the mechanism of radon induced lung cancer in uranium
miners.
3) to utilize data on uranium miners to assess the effect of low level radon
exposure in the general population.
B. Methodology: In this study we are generating comprehensive tracheal bronchial trees from lung cancer patients to aid in the characterization of lung tumor progression. Non-small cell lung carcinomas and their precursor lesions will be examined from the following groups of patients: Group I - uranium miners who were smokers; Group II - uranium miners who were not smokers; and Group III - smokers who were not miners. Comparisons between Groups I and III will generate data to address the hypotheses that radon exposure plus smoking either induces different genetic lesions or induces lesions at different stages of tumor development than does smoking alone. Observations made on Group II will either confirm or refute the comparisons between Groups I and III.
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: Archival material on patients diagnosed with primary bronchogenic carcinoma will make up this study group. The selection of these study subjects will primarily include men above 50 years of age based on the known demographic characteristics of uranium mine workers. Subjects will also reflect the ethnic and racial components of the mining industry of the Colorado Plateau. The clinical subjects chosen for parallel studies will be selected from St. Mary's hospital patient base. The hospital does not discriminate on the basis of age, race, color, creed or ethnic background.
1. Procedures of protection of " Patient rights" regarding the use of archival samples: Confidentiality is maintained at all times. Samples used for analysis are coded with the "Early Lesion Study" (ELS) prefix, year of study enrollment, and enrollment number (ELS 93-000). Subject keys are maintained in subject file which is stored with all study information in a locked cabinet with controlled access.
2. Risks: Archived biological samples are used in this study. This study provides lung cancer patients and their families with a unique opportunity to better understand the molecular makeup and possible pathways to lung cancer genesis. The knowledge gained from such studies is critical to the issues of environmental exposure both in the work place and the home from radon progeny, its cause and effect on the development of this disease. In the event a subject or family member questions the use of unidentified archival tissue samples or the results of such studies, the person(s) involved will be directed to the Chairman of the IRB.
Project Identifier: SMHCRI-95-DE-FG03-95ER62060/A0
Project Title:
Identification of Human Lung Cancer Susceptibility Genes
Principal Investigator:
Dr. Marshall Anderson
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
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: 96-00013
Number of Human Subjects who participated in this project/protocol during
08/01/95 - 07/31/96: 59
Type of Human Subjects Involvement:
A. Objective: Only 20% of all smokers develop lung cancer. Genetic epidemiological studies of familial lung cancer imply the involvement of a susceptibility gene(s). These data are consistent with the hypothesis that genetic predisposition to lung cancer is expressed only in individuals who smoke or are exposed to other environmental insults. The primary objective of this project is to characterize the susceptibility gene(s) and develop blood tests to identify individuals who are predisposed to develop lung cancer.
B. Methodology: Families chosen for this study include approximately equal numbers of both sexes from patients reflecting the ethnic and racial components of the Colorado Plateau and areas served by St. Mary's Hospital and Medical Center. Comprehensive pedigrees of at least ten families with extensive histories of pulmonary neoplasia will be compiled. The pedigrees will be completed with clinical, smoking, occupational (e.g. uranium mining) and environmental exposure data. Detailed exposure history questionnaires will be completed for each family member whether living or deceased. Study families living in close proximity with St. Mary 's will be asked to schedule time for an interview. This interview will include a complete explanation of the project and our expectations in regards to availability of health related information and Biological samples and if agreed, a signed consent form. Non-local family members will be contacted by telephone and/or mail. Arrangements will be made for their physicians to collect and mail blood samples to St. Mary's. All information and specimens will be obtained and handled in a confidential manner. 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 preformed 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. Non-related individuals (by blood or marriage), are not included in the study.
3. Study subjects will be asked to sign a medical release of information form.
4. 20 - 40 ml of venous blood from each participating living family member.
All tissue samples, blood, paraffin embedded sections, and fresh tissue samples will be specifically collected from study subjects for research purposed. All information and specimens will be obtained and handled in a confidential manner. Enrollment is voluntary and any enrollee may terminate his/her participation in the study without any consequences.
D/2 The risks associated with venipuncture draw include possibility of pain, slight bleeding, fainting and infection. Standard phlebotomy techniques will be practiced. Patients will be given instructions on care of the venipuncture site. Subjects will be monitored for any stress during interview and/or blood draw. Appropriate phone numbers will be given in the event physical or mental complications occur at a later time. While there is no direct benefit to the participants for joining this study, information may be gained about the existence and possible location of the gene(s) that may interact with environmental carcinogens, including smoking, which increase the risk of lung cancer or other smoking associated cancers. In the event such a linkage is identified, individuals at risk will be recontacted for appropriate counselling.
Project Identifier: SMHCRI-97-DE-FG02-90E60939
Project Title:
Eary Lung Cancer Detection in Uranium Miners with Abnormal Sputum Cyology
Principal Investigator:
Dr. Geno Saccomanno
Project started in: 1997
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 01, 1995
Number of Human Subjects who participated in this project/protocol during
04/01/95 - 03/31/95: 270
Type of Human Subjects Involvement:
A. Objectives: The primary objectives of this project are to identify underground uranium miner who are at high risk for the development of lung cancer; 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 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 which 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.