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Relatively Healthy Male Veterans Observed Over Time to See What Types of Diseases Develop (ACTIVE Health)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00076141
First received: January 14, 2004
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CSP #499A - Selenium and Vitamin E Cancer Prevention Trial - COHORT

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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. [ Time Frame: Every six months for at least five years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

PE and buffy coat


Enrollment: 991
Study Start Date: January 2002
Estimated Study Completion Date: January 2016
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • relatively healthy male veterans
  • at least 50 years old
Criteria

Inclusion Criteria:

  • relatively healthy male veterans
  • at least 50 years old

Exclusion Criteria:

  • Life expectancy of at least 5 yrs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076141

Locations
United States, California
VA Medical Center, Loma Linda
Loma Linda, California, United States, 92357
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Missouri
VA Medical Center, Kansas City MO
Kansas City, Missouri, United States, 64128
United States, New York
VA Medical Center, Northport
Northport, New York, United States, 11768
VA Medical Center, Syracuse
Syracuse, New York, United States, 13210
United States, Tennessee
James H. Quillen VA Medical Center
Mountain Home, Tennessee, United States, 37684
United States, West Virginia
VA Medical Center, Huntington
Huntington, West Virginia, United States, 25704
Sponsors and Collaborators
Investigators
Study Chair: Michael J. Gaziano, MD MOH VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00076141     History of Changes
Other Study ID Numbers: 499A
Study First Received: January 14, 2004
Last Updated: July 11, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
relatively healthy male

ClinicalTrials.gov processed this record on November 25, 2014