HealthyACTIVE HealthNCT00076141
Relatively Healthy Male Veterans Observed Over Time to See What Types of Diseases Develop
An observational study of Healthy, run by VA Office of Research and Development at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 991 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Jan 2002to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: * relatively healthy male Veterans * at least 50 years old
Who may be able to join
- relatively healthy male Veterans
- at least 50 years old
Who cannot join
- Life expectancy of at least 5 yrs
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000
VA Medical Center, Huntington
Huntington, West Virginia, 25704
VA Medical Center, Kansas City MO
Kansas City, Missouri, 64128
VA Medical Center, Loma Linda
Loma Linda, California, 92357
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417
James H. Quillen VA Medical Center
Mountain Home, Tennessee, 37684
VA Medical Center, Northport
Northport, New York, 11768
VA Medical Center, Syracuse
Syracuse, New York, 13210
About this study
Official title: CSP #499A - Selenium and Vitamin E Cancer Prevention Trial - COHORT
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.
Read the 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
- Keywords
- relatively healthy male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Older, Racially Diverse Males | Racially Divers Males over 50, expected to live more than 5 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every six months for at least five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2004 (estimated)
- Study start1 Jan 2002
- Primary completion1 Jan 2014
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 991 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michael J Gaziano, MD MPH, Study chair, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076141
- Sponsor's protocol ID
- 499A
- Acronym
- ACTIVE Health
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2004
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #499A - Selenium and Vitamin E Cancer Prevention Trial - COHORT
- ClinicalTrials.gov ID
- NCT00076141
- Acronym / sponsor ID
- ACTIVE Health / 499A
- Conditions
- Healthy
- Keywords
- relatively healthy male
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 991 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2002 (actual)
- Primary completion
- 1 Jan 2014 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 16 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older, Racially Diverse Males | – | –Racially Divers Males over 50, expected to live more than 5 years |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * relatively healthy male Veterans * at least 50 years old
Key inclusion criteria (2 listed)
- relatively healthy male Veterans
- at least 50 years old
Key exclusion criteria (1 listed)
- Life expectancy of at least 5 yrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Gaziano, MD MPH study chair
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by VA Office of Research and Development at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Chronic Conditions in African American and White Male Veterans (time frame: Every six months for at least five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.