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

NCT ID: NCT00076141

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 991 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-01-01
• Study Completion Date: 2021-01-01

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.

Conditions

Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Older, Racially Diverse Males

Racially Divers Males over 50, expected to live more than 5 years

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• relatively healthy male Veterans
• at least 50 years old

Exclusion Criteria

• Life expectancy of at least 5 yrs

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J Gaziano, MD MPH

Role: STUDY_CHAIR

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

Locations

VA Medical Center, Loma Linda

Loma Linda, California, United States

Edward Hines, Jr. VA Hospital

Hines, Illinois, United States

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

Boston, Massachusetts, United States

VA Medical Center, Minneapolis

Minneapolis, Minnesota, United States

VA Medical Center, Kansas City MO

Kansas City, Missouri, United States

VA Medical Center, Northport

Northport, New York, United States

VA Medical Center, Syracuse

Syracuse, New York, United States

James H. Quillen VA Medical Center

Mountain Home, Tennessee, United States

VA Medical Center, Huntington

Huntington, West Virginia, United States

Countries

United States

Other Identifiers

499A

Identifier Type: -

Identifier Source: org_study_id