Clinical trial NCT00032578: VA Genetic Tissue Banking
Official title: CSP #478 (FeAST-DNA), Genetic Tissue Banking in VA Clinical Research: A Cooperative Studies Program Demonstration Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tissue Banking
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2002-03-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This project is a program-wide genetic tissue databank for the Department of Veterans Affairs Cooperative Studies Program (CSP). The genetic tissue bank has four components: a central repository for DNA and other genetic tissue specimens; a Scientific Advisory Committee of individuals with expertise in the genetics and epidemiology of diseases with special importance to the VA (including cardiovascular, neurologic, respiratory, psychological and other disorders); an Ethics Oversight Committee of individuals with expertise in bioethics and the law, as they apply to the collection and use of genetic tissue, and a Coordinating Center that administers the tissue bank, coordinates the scientific and ethics oversight committees, maintains central access to clinical study data linked to the tissue bank, and provides statistical analysis.

Detailed description: Intervention: No intervention.

Primary Hypothesis: It is feasible and cost-effective to create a CSP-wide facility for banking genetic tissue in CSP studies.

Study Abstract: This is a program-wide genetic tissue databank for the Department of Veterans Affairs Cooperative Studies Program (CSP). The study has five components: a central repository for DNA and other genetic tissue specimens; a Scientific Advisory Committee of individuals with expertise in the genetics and epidemiology of diseases with special importance to the VA (including cardiovascular, neurologic, respiratory, psychological and other disorders); an Ethical Oversight Committee of individuals with expertise in bioethics and the law, as they apply to the collection and use of genetic tissue, A Veteran's Advisory Group, and a Coordinating Center administers the tissue bank, coordinates the three oversight committees, maintains central access to clinical study data linked to the tissue bank, and provides statistical analysis.

Eligibility criteria: This DNA Banking substudy piggybacks on VA Cooperative Studies Clinical Trials. All participants who are randomized to selected CSP clinical trials are eligible to participate in the Banking Initiative.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Little Rock VAMC
state: Arkansas
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Louisville
country: United States
facility: Louisville VAMC
state: Kentucky
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: Pittsburgh
country: United States
facility: VA Pittsburgh Health Care System
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Salt Lake City VA Medical Center
state: Utah
city: White River Junction
country: United States
facility: White River Junction VAMC
state: Vermont
city: Madison
country: United States
facility: Madison VA Medical Center
state: Wisconsin
Study officials:
References: