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OpenTrials
Completed

NCT Number: NCT00076141

Relatively Healthy Male Veterans Observed Over Time to See What Types of Diseases Develop

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.

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Key information

Conditions

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Primary location

VA Medical Center, Loma Linda, Loma Linda, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • relatively healthy male Veterans
  • at least 50 years old

Exclusion criteria

  • Life expectancy of at least 5 yrs

Treatment and study plan

Primary outcomes

  1. Prevalence of Chronic Conditions in African American and White Male Veterans

    Time frame: Every six months for at least five years

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: ACTIVE Health

Important dates

Study start
2002
Primary completion
2014
Study completion
2021
First posted
Jan 16, 2004
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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