Mr. Peter Moberg
St. Mary's Hospital and Medical Center
P.O. Box 1628
Grand Junction, CO 81502-1628
Phone: 970-244-2000
Fax: 970-244-7510
Email: n/a
Projects are approved by an IRB located at: St. Mary's Hospital and Medical Center.
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: 1
Project Identifier: SMHMC-77-DEFG0290ER60939
Project Title:
Early Lung Cancer Detection in Uranium Miners With Abnormal Sputum Cytology
Principle Investigator:
Dr. Geno Saccomanno
Project started in: 1977
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
Funding Sources:
This is for labor expenses and supplies used for Uranium Miners, a group of high risk individuals, participating through sputum cytology, a medical lab test for early lung cancer.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 27, 1994
IRB Approval Number: 94-0006
Number of Human Subjects in the Last Reporting Period for this Project: 276
(Reporting periods vary.)
Type of Human Subjects Involvement:
The primary objectives of this project are to identify underground uranium miners who are at high risk for the development of lung cancer, to monitor sputum cytologic samples from these individuals for morphologic changes consistent with a neoplastic process, and to continue collecting epidemiological data for inclusion in the Saccomanno Uranium Miner Archive.
Cytologic surveillance continues on a group of 276 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 degree of cellular abnormality. The collected samples are assigned 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 bronchiogenic carcinoma has been confirmed, either cytologically or pathologically, the subject is entered into 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.
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.
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 dialog with the miner, which includes information regarding eligibility and project protocols. The Institutional Review Board's (IRB) approved subject consent form is included in the packet. After the subject has returned the signed written consent form, he or 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 the bottle. Upon return of the sample to the laboratory, it is processed and evaluated, and a diagnosis is given. The results are communicated to the attending physician. As with any other laboratory test, 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 that 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 than those ordinarily encountered in daily life or during the performance of routine physical... examination---" (e.g., routine coughing up of mucus material and spitting it into a handkerchief or tissue to clear airways.)
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 diagnose 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.