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

This study is currently recruiting participants.
Verified by Department of Veterans Affairs, August 2008

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00076141
  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

MedlinePlus related topics:   Cancer   

Drug Information available for:   Vitamin E    alpha-Tocopherol    alpha-Tocopheryl acetate    Tocopherols    Selenium   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   CSP #499(A) - 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

Biospecimen Description:

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)

Groups/Cohorts
1

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

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

Contacts
Contact: Caterina Brown     caterina.brown@va.gov    
Contact: Michelle Skornicki     (857) 364-4875     michelle.skornicki@va.gov    

Locations
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    

Sponsors and Collaborators

Investigators
Study Chair:     Michael J. Gaziano, MD MOH     VA Boston Health Care System    
  More Information


Responsible Party:   Department of Veterans Affairs ( Gaziano, Michael - Study Chair )
Study ID Numbers:   499A
First Received:   January 14, 2004
Last Updated:   August 8, 2008
ClinicalTrials.gov Identifier:   NCT00076141
Health Authority:   United States: Federal Government

Keywords provided by Department of Veterans Affairs:
relatively healthy male  

Study placed in the following topic categories:
Tocopherols
Selenium
Tocopherol acetate
Vitamin E
Healthy
Alpha-Tocopherol

ClinicalTrials.gov processed this record on November 20, 2008




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