Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076141
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2004-01-14
Brief Title:
Relatively Healthy Male Veterans Observed Over Time to See What Types of Diseases Develop
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 499A - Selenium and Vitamin E Cancer Prevention Trial - COHORT
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACTIVE Health
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 16000 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 16000 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None