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


N/A
50 Years
N/A
Open (Enrolling)
Male
Healthy

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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.


Inclusion Criteria:



- relatively healthy male veterans

- at least 50 years old

Exclusion Criteria:

- Life expectancy of at least 5 yrs

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To determine whether differences in the prevalence of common chronic conditions affecting older veterans among African-American and white male veterans are explained by medical, lifestyle, dietary, or other risk factors.

Outcome Time Frame:

Every six months for at least five years

Safety Issue:

No

Principal Investigator

Michael J. Gaziano, MD MOH

Investigator Role:

Study Chair

Investigator Affiliation:

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Authority:

United States: Federal Government

Study ID:

499A

NCT ID:

NCT00076141

Start Date:

January 2002

Completion Date:

January 2016

Related Keywords:

  • Healthy
  • relatively healthy male

Name

Location

Edward Hines, Jr. VA Hospital Hines, Illinois  60141-5000
VA Medical Center, Syracuse Syracuse, New York  13210
VA Medical Center, Kansas City MO Kansas City, Missouri  64128
VA Medical Center, Northport Northport, New York  11768
VA Medical Center, Huntington Huntington, West Virginia  25704
VA Medical Center, Minneapolis Minneapolis, Minnesota  55417
VA Medical Center, Loma Linda Loma Linda, California  92357
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston, Massachusetts  02130
James H. Quillen VA Medical Center Mountain Home, Tennessee  37684