Trial Information

CSP #499A - Selenium and Vitamin E Cancer Prevention Trial - COHORT

The purpose of this study is to gather a mixed racial group of relatively healthy male
veterans (for example, White, African-American, and Hispanic), who are at least 50 years of
age. These men will be followed to see what types of diseases they develop and to determine
if racial differences in lifestyle, blood test results, or genes are related to the types of
diseases that are found. Diseases of particular interest are prostate cancer, other cancers,
cardiovascular disease (for example, heart attacks and stroke), high blood pressure and
diabetes. The group to be followed will consist of about 16,000 men recruited from about 40
VA Medical Centers across the country. Each man will be followed for at least five years
depending on when he enters the study.

Participants are asked to complete a set of forms to provide a brief medical history,
demographics, information on lifestyle such as physical activities, smoking, and drinking,
information on diet, and information on quality of life.

Subjects will be seen on a biannual basis with follow-up telephone interviews conducted
during the intervening years. Follow-up telephone interviews will be conducted at the
MAVERIC Call Center while follow-up clinic visits will take place at each SELECT site. In
addition, VA clinical and administrative databases will be used to augment follow-up and
confirm reported events.

During follow-up visits, participants will be asked whether they experienced any medical
events since the last study visit, with information on specific diagnoses including prostate
cancer, lung cancer, colon cancer, other cancers, stroke, myocardial infarction,
hypertension, diabetes mellitus, kidney disease, chronic prostatitis, and benign prostatic
hypertrophy. Confirmation of self-reported diagnosis will be made by an examination of
discharge summaries, medical records, and available diagnostic and laboratory information by
an end-points committee.

Recruitment for this observational cohort will proceed in parallel with recruitment for
SELECT and can use SELECT staff and resources with very little additional burden in cost or
staff time.