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Gulf War Era Cohort and Biorepository (CSP# 585)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01803854
First received: February 14, 2013
Last updated: July 31, 2017
Last verified: July 2017
  Purpose

The Gulf War Era Cohort and Biorepository pilot project collected epidemiological, survey, clinical, and environmental exposure data from Veterans who served during the 1990-1991 Gulf War Era. Approved researchers will be able to use these data and the blood samples to do future research about the health of Gulf War Era Veterans.

During the pilot, the recruitment response rate and processes were assessed. The results revealed several opportunities for improvement. For this reason, CSP 585 research activities transitioned to a qualitative phase to focus more on the Veteran voice. In this stage, research staff spoke with Gulf War Era Veterans through focus groups, interviews, and other activities such as events and meetings to learn more about Veterans' experiences and/or ideas on this and other Gulf War research projects. This phase provided new information that can help researchers create better recruitment processes for future projects involving Gulf War Era Veterans.

For more information on CSP 585, please contact Kristina Felder at 919-286-0411 ext. 7379 or Kristina.Felder@va.gov.


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 VA Office of Research and Development:

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: 4 years ]
    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 was collected from participants. All specimens have been processed and stored at the VA Central Biorepository (VACB) for use in future research. One vial of buffy coat containing the DNA is stored. One aliquot of plasma was also extracted for storage from all samples.

Estimated Enrollment: 1276
Actual Study Start Date: September 2, 2014
Estimated Study Completion Date: September 30, 2018
Estimated Primary Completion Date: September 30, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gulf War Era Veterans
All Veterans who served in the uniformed services during 1990-1991 who signed consent forms, completed a survey, and provided a blood sample are included in the cohort.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Locations
United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Study Chair: Dawn Provenzale, MD MS Durham VA Medical Center, Durham, NC
  More Information

Additional Information:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01803854     History of Changes
Other Study ID Numbers: 585
11-09 ( Other Identifier: Central IRB )
Study First Received: February 14, 2013
Last Updated: July 31, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

ClinicalTrials.gov processed this record on August 18, 2017