Clinical trial NCT00076141: Relatively Healthy Male Veterans Observed Over Time to See What Types of Diseases Develop
Official title: CSP #499A - Selenium and Vitamin E Cancer Prevention Trial - COHORT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: relatively healthy male
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2004-01-16
Enrollment: 991
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * relatively healthy male Veterans
* at least 50 years old

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* relatively healthy male Veterans
* at least 50 years old

Exclusion Criteria:

* Life expectancy of at least 5 yrs

Primary outcomes:
measure: Prevalence of Chronic Conditions in African American and White Male Veterans
timeFrame: Every six months for at least five years
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: VA Medical Center, Loma Linda
state: California
city: Hines
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
city: Minneapolis
country: United States
facility: VA Medical Center, Minneapolis
state: Minnesota
city: Kansas City
country: United States
facility: VA Medical Center, Kansas City MO
state: Missouri
city: Northport
country: United States
facility: VA Medical Center, Northport
state: New York
city: Syracuse
country: United States
facility: VA Medical Center, Syracuse
state: New York
city: Mountain Home
country: United States
facility: James H. Quillen VA Medical Center
state: Tennessee
city: Huntington
country: United States
facility: VA Medical Center, Huntington
state: West Virginia
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Michael J Gaziano, MD MPH
role: STUDY_CHAIR
References: