Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Department of Veterans Affairs |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00076141 |
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: | Cohort, Prospective |
Official Title: | CSP #499(A) - Selenium and Vitamin E Cancer Prevention Trial - COHORT |
PE and buffy coat
Estimated Enrollment: | 16000 |
Study Start Date: | January 2002 |
Estimated Study Completion Date: | January 2016 |
Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Life expectancy of at least 5 yrs.
Contact: Caterina Brown | caterina.brown@va.gov | |
Contact: Michelle Skornicki | (857) 364-4875 | michelle.skornicki@va.gov |
United States, Arizona | |
Carl T. Hayden VA Medical Center | Active, not recruiting |
Phoenix, Arizona, United States, 85012 | |
United States, California | |
VA Medical Center, Loma Linda | Recruiting |
Loma Linda, California, United States, 92357 | |
Contact: Lynetta Skoretz, MD 909-825-7084 ext 3176 lynetta.skoretz@med.va.gov | |
United States, Illinois | |
Jesse Brown VAMC (WestSide Division) | Active, not recruiting |
Chicago, Illinois, United States, 60612 | |
Edward Hines, Jr. VA Hospital | Recruiting |
Hines, Illinois, United States, 60141-5000 | |
Contact: Nirmala Bhoopalam, MD 708-202-8387 ext 21430 NIRMALA.BHOOPALAM@MED.VA.GOV | |
United States, Massachusetts | |
VA Boston Health Care System | Recruiting |
Brockton, Massachusetts, United States, 02401 | |
Contact: Michael J Gaziano, MD MOH 857-364-4201 michael.gaziano@va.gov | |
Contact: John Hermos, MD (857) 364-6130 ext 4-6130 john.hermos@va.gov | |
Study Chair: Michael J. Gaziano, MD MOH | |
United States, Minnesota | |
VA Medical Center, Minneapolis | Recruiting |
Minneapolis, Minnesota, United States, 55417 | |
Contact: Timothy J Wilt, MD 612-725-2158 tim.wilt@med.va.gov | |
United States, Missouri | |
VA Medical Center, Kansas City MO | Recruiting |
Kansas City, Missouri, United States, 64128 | |
Contact: Peter Van Veldhuizen, MD 816-861-4700 ext 6755 vanveldhuizen.peter@kansas-city.va.gov | |
VA Medical Center, St Louis | Not yet recruiting |
St Louis, Missouri, United States, 63106 | |
Contact: Melvin Blanchard, MD 314-652-4100 ext 4482 melvin.blanchard@med.va.gov | |
United States, New York | |
VA Western New York Healthcare System at Buffalo | Active, not recruiting |
Buffalo, New York, United States, 14215 | |
VA Medical Center, Northport | Recruiting |
Northport, New York, United States, 11768 | |
Contact: Mohammad H. Zarrabi, MD, PhD 631-261-4400 ext 2581/2586 mohammad.zarrabi@med.va.gov | |
VA Medical Center, Syracuse | Recruiting |
Syracuse, New York, United States, 13210 | |
Contact: Imad Nsouli, MD 315-425-4400 ext 53579 IMAD.NSOULI@MED.VA.GOV | |
United States, Pennsylvania | |
VA Pittsburgh Health Care System | Not yet recruiting |
Pittsburgh, Pennsylvania, United States, 15240 | |
Contact: Thomas R Hakala, MD 412-688-6209 hakalatr@msx.upmc.edu | |
United States, Rhode Island | |
VA Medical Center, Providence | Active, not recruiting |
Providence, Rhode Island, United States, 02908 | |
United States, Tennessee | |
James H. Quillen VA Medical Center | Recruiting |
Mountain Home, Tennessee, United States, 37684 | |
Contact: Anand Karnad, MD 423-433-6210 anand.karnad@med.va.gov | |
United States, West Virginia | |
VA Medical Center, Huntington | Recruiting |
Huntington, West Virginia, United States, 25704 | |
Contact: Sandra Prunty, RN, PhD 304-429-6755 ext 3530 sandra.prunty@med.va.gov |
Study Chair: | Michael J. Gaziano, MD MOH | VA Boston Health Care System |
Responsible Party: | Department of Veterans Affairs ( Gaziano, Michael - Study Chair ) |
Study ID Numbers: | 499A |
Study First Received: | January 14, 2004 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00076141 |
Health Authority: | United States: Federal Government |
relatively healthy male |
Tocopherols Selenium Tocopherol acetate |
Vitamin E Healthy Alpha-Tocopherol |