Gulf War Era Cohort and Biorepository (CSP# 585)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01803854
First received: February 14, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

The project will integrate epidemiological, survey, clinical, and environmental exposure data of the Gulf War era cohort. Blood specimens will be used to establish the biorepository. The goal is to enable the availability of blood specimens and the research database for a wide range of future genomic and genetic studies, biologic and immunologic research, and epidemiological, clinical, and health services research. This pilot project represents the initial implementation of the cohort and biorepository. During the pilot, the recruitment response rate and other operational and logistical aspects will be assessed to provide support for the full-scale study.


Condition
Gulf War Era Cohort

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CSP # 585 - Pilot Study: Gulf War Era Cohort and Biorepository

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The topics that will be measured by the survey are military service, lifestyle behaviors, physical and mental health, and family (including family health). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Blood specimens and the research database will be made available for a wide range of future genomic and genetic studies, biologic and immunologic research, and epidemiological, clinical, and health services research.


Biospecimen Retention:   Samples With DNA

One EDTA tube of blood will be collected from participants. All specimens will be processed and stored at the VA Central Biorepository (VACB) for use in future research. One vial of buffy coat containing the DNA will be stored. One aliquot of plasma will also be extracted for storage from all samples.


Estimated Enrollment: 3000
Study Start Date: August 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gulf War Era Veterans
Those who served in the military between 1990-1991 without regard to actual deployment to Southwest Asia.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Veterans who served in the military in 1990-1991 without regard to actual deployment.

Criteria

Inclusion Criteria:

  • A potential participant must have been a member of the uniformed services during the 1990-1991 Gulf War era.
  • A Veteran is eligible without regard to deployment or combat status and without regard to current or past user status in the Veterans Health Administration.

Exclusion Criteria:

  • Veterans who did not serve in the military in 1990-1991 without regard to actual deployment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803854

Contacts
Contact: Lara Khalil, MPH lara.Khalil@va.gov
Contact: Kendrick Gray (919) 286-0411 ext 4010 kendrick.gray@va.gov

Locations
United States, North Carolina
Durham VA Medical Center Not yet recruiting
Durham, North Carolina, United States, 27705
Contact: Dawn Provenzale, MD MS    919-416-8022    dawn.provenzale@va.gov   
Study Chair: Dawn Provenzale, MD MS         
Sub-Investigator: Karen Goldstein, MD         
Sponsors and Collaborators
Investigators
Study Chair: Dawn Provenzale, MD MS Durham VA Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01803854     History of Changes
Other Study ID Numbers: 585, 11-09
Study First Received: February 14, 2013
Last Updated: July 23, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on September 18, 2014