NCT00076141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
991

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2004

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

12 years

First QC Date

January 14, 2004

Last Update Submit

January 29, 2021

Conditions

Keywords

relatively healthy male

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Chronic Conditions in African American and White Male Veterans

    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.

    Every six months for at least five years

Study Arms (1)

Older, Racially Diverse Males

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

Eligibility Criteria

Age50 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Details* relatively healthy male Veterans * at least 50 years old
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* relatively healthy male Veterans * at least 50 years old

You may qualify if:

  • relatively healthy male Veterans
  • at least 50 years old

You may not qualify if:

  • Life expectancy of at least 5 yrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

VA Medical Center, Loma Linda

Loma Linda, California, 92357, United States

Location

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-5000, United States

Location

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

Boston, Massachusetts, 02130, United States

Location

VA Medical Center, Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

VA Medical Center, Kansas City MO

Kansas City, Missouri, 64128, United States

Location

VA Medical Center, Northport

Northport, New York, 11768, United States

Location

VA Medical Center, Syracuse

Syracuse, New York, 13210, United States

Location

James H. Quillen VA Medical Center

Mountain Home, Tennessee, 37684, United States

Location

VA Medical Center, Huntington

Huntington, West Virginia, 25704, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

PE and buffy coat

Study Officials

  • Michael J Gaziano, MD MPH

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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2004

First Posted

January 16, 2004

Study Start

January 1, 2002

Primary Completion

January 1, 2014

Study Completion

January 1, 2021

Last Updated

February 1, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations