Relatively Healthy Male Veterans Observed Over Time to See What Types of Diseases Develop (ACTIVE Health)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00076141|
Recruitment Status : Active, not recruiting
First Posted : January 16, 2004
Last Update Posted : March 5, 2018
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||991 participants|
|Official Title:||CSP #499A - Selenium and Vitamin E Cancer Prevention Trial - COHORT|
|Actual Study Start Date :||January 1, 2002|
|Actual Primary Completion Date :||January 1, 2014|
|Estimated Study Completion Date :||January 1, 2021|
Older, Racially Diverse Males
Racially Divers Males over 50, expected to live more than 5 years
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076141
|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|
|Study Chair:||Michael J Gaziano, MD MPH||VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|