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Gulf War Era Cohort and Biorepository (CSP# 585)

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ClinicalTrials.gov Identifier: NCT01803854
Recruitment Status : Active, not recruiting
First Posted : March 4, 2013
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date February 14, 2013
First Posted Date March 4, 2013
Last Update Posted Date September 4, 2019
Actual Study Start Date September 2, 2014
Actual Primary Completion Date July 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 23, 2015)
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.
Original Primary Outcome Measures
 (submitted: February 28, 2013)
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: 5 years ]
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.
Change History Complete list of historical versions of study NCT01803854 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gulf War Era Cohort and Biorepository
Official Title CSP # 585 - Pilot Study: Gulf War Era Cohort and Biorepository
Brief Summary

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 Abigail Shapiro at Abigail.Shapiro@va.gov.

Detailed Description

To date, the Department of Veterans Affairs (VA), the Department of Defense (DoD), and the Department of Health and Human Services have funded many research projects pertaining to the health consequences of military service in the 1990-1991 Gulf War. This past research represents a tremendous investment into understanding the medical conditions of these Veterans. However, many important questions remain to be answered about conditions affecting Gulf War Era Veterans. In addition, the Gulf War Era Veteran population is entering the age range at which the incidence of chronic diseases increases rapidly, and other questions are arising regarding the health and medical care of this important cohort.

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. The goal was to enable the availability of blood specimens and health information for future immunologic, epidemiological, clinical, and health services research. During the pilot, the recruitment response rate and other operational and logistical aspects were assessed. Results indicated that our current recruitment processes were suboptimal for achieving our desired number of participants, and provide opportunities for improvement. To this end, CSP 585 research activities transitioned to a qualitative phase to focus more on the Veteran voice and learn more about how to effectively recruit Gulf War Era Veterans for a project like this. This phase provided new information that will inform recruitment processes for future projects involving Gulf War Era Veterans.

Specific Aims - The Gulf War Era Cohort and Biorepository pilot project was a minimal risk observational pilot project to test the processes needed to establish a research cohort and biorepository of Gulf War Era Veterans. There were no research questions or hypotheses. The pilot project had two specific aims:

  1. assess the feasibility and efficacy of the planned recruitment, consenting, and blood drawing and shipping processes, and of modifications to the processes (if necessary); and
  2. develop, test, and implement the database structures required for subject enrollment tracking, blood sample tracking, and data storage.

Veterans of the Gulf War Era were identified largely through existing VA and Department of Defense registries and databases. Some Veterans voluntarily joined and were eligible if they served in the military during 1990-91 without regard to actual deployment. The study database contains information collected from the Gulf War Era Veterans' Survey. Additional data will be collected from national VA and non-VA resources and from other studies of Gulf War Era Veterans.

Importance - There has been substantial research into the health care needs of Gulf War Era Veterans, but the incidence of chronic diseases that should be expected as this population ages is uncertain. Furthermore, the relationships between exposures, genetic susceptibility, and these illnesses have not been explored comprehensively in a large cohort. Data from the cohort described in this protocol includes both survey and blood-based biomarkers, which can provide valuable resources for identifying risk factors as well as other chronic and aging related diseases. These data can then be used to identify the current and future health care needs of Gulf War Era Veterans to more effectively target programs towards them.

The intended users of the Gulf War Era Research Database and blood specimens are researchers who are specifically interested in illnesses affecting Gulf War Era Veterans, and researchers interested in the physical and mental health concerns that affect a population of this age group. The availability of a research cohort with the particular demographics and the documented experiences of Gulf War Era service will enable more detailed analyses regarding diagnosis and treatment of conditions affecting an aging population than is possible with administrative databases alone. With insights from analyses of data and blood specimens from this project, as well as others, the VA will be better able to focus interventions to improve diagnosis, treatment, and outcomes of care.

For more information on CSP 585, please contact Abigail Shapiro at Abigail.Shapiro@va.gov.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
One EDTA tube of blood was collected from participants. All specimens have been processed and stored at the VA Central Biorepository (VACB) and its backup location 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.
Sampling Method Probability Sample
Study Population Veterans who served in the military in 1990-1991 without regard to actual deployment.
Condition Gulf War Era Cohort
Intervention Not Provided
Study 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.
Publications * Khalil L, McNeil RB, Sims KJ, Felder KA, Hauser ER, Goldstein KM, Voils CI, Klimas NG, Brophy MT, Thomas CM, Whitley RL, Dursa EK, Helmer DA, Provenzale DT. The Gulf War Era Cohort and Biorepository: A Longitudinal Research Resource of Veterans of the 1990-1991 Gulf War Era. Am J Epidemiol. 2018 Nov 1;187(11):2279-2291. doi: 10.1093/aje/kwy147.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: January 4, 2018)
1275
Original Estimated Enrollment
 (submitted: February 28, 2013)
30000
Estimated Study Completion Date July 21, 2021
Actual Primary Completion Date July 21, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01803854
Other Study ID Numbers 585
11-09 ( Other Identifier: Central IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor VA Office of Research and Development
Collaborators Not Provided
Investigators
Study Chair: Dawn Provenzale, MD MS Durham VA Medical Center, Durham, NC
PRS Account VA Office of Research and Development
Verification Date September 2019