Gulf War Era CohortCSP# 585NCT01803854
Gulf War Era Cohort and Biorepository
An observational study of Gulf War Era Cohort, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gulf War Era Cohort
- How many people
- 1,275 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2014to 20 Jul 2027
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Veterans who served in the military in 1990-1991 without regard to actual deployment.
Who may be able to join
- 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.
Who cannot join
- Veterans who did not serve in the military in 1990-1991 without regard to actual deployment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
About this study
Official title: CSP # 585 - Pilot Study: Gulf War Era Cohort and Biorepository
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 Asia Johnson at asia.johnson4@va.gov and Christina Williams at christina.williams4@va.gov
Read the 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:
- 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
- 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 survey data, plasma and access to VA and non-VA medical records, 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 Asia Johnson at asia.johnson4@va.gov and Christina Williams at christina.williams4@va.gov
- Conditions
- Gulf War Era Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VHA Health Care Utilization
Use of VHA for health care in the past year
Measured: 20 months
Deployment
Deployment in support of 1990-1991 Gulf War
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study start2 Sep 2014
- Primary completion21 Jul 2019
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Gulf War Era CohortStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,275 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dawn Provenzale, MD MS, Study chair, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803854
- Sponsor's protocol ID
- 585
- Other IDs
- 11-09
- Acronym
- CSP# 585
- Status last verified
- Aug 2026
- First submitted
- 14 Feb 2013
- Last updated
- 15 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30060060Brown MC, Sims KJ, Gifford EJ, Goldstein KM, Johnson MR, Williams CD, Provenzale D. Gender-based Differences among 1990-1991 Gulf War Era Veterans: Demographics, Lifestyle Behaviors, and Health Conditions. Womens Health Issues. 2019 Jun 25;29 Suppl 1(Suppl 1):S47-S55. doi: 10.1016/j.whi.2019.04.004.
PubMed 31253242Vahey J, Hauser ER, Sims KJ, Helmer DA, Provenzale D, Gifford EJ. Research tool for classifying Gulf War illness using survey responses: Lessons for writing replicable algorithms for symptom-based conditions. Life Sci. 2021 Oct 1;282:119808. doi: 10.1016/j.lfs.2021.119808. Epub 2021 Jul 6.
PubMed 34242657Gifford EJ, Vahey J, Hauser ER, Sims KJ, Efird JT, Dursa EK, Steele L, Helmer DA, Provenzale D. Gulf War illness in the Gulf War Era Cohort and Biorepository: The Kansas and Centers for Disease Control definitions. Life Sci. 2021 Aug 1;278:119454. doi: 10.1016/j.lfs.2021.119454. Epub 2021 Mar 31.
PubMed 33811897Vahey J, Gifford EJ, Sims KJ, Chesnut B, Boyle SH, Stafford C, Upchurch J, Stone A, Pyarajan S, Efird JT, Williams CD, Hauser ER. Gene-Toxicant Interactions in Gulf War Illness: Differential Effects of the PON1 Genotype. Brain Sci. 2021 Nov 25;11(12):1558. doi: 10.3390/brainsci11121558.
PubMed 34942860Gifford EJ, Boyle SH, Vahey J, Sims KJ, Efird JT, Chesnut B, Stafford C, Upchurch J, Williams CD, Helmer DA, Hauser ER. Health-Related Quality of Life by Gulf War Illness Case Status. Int J Environ Res Public Health. 2022 Apr 7;19(8):4425. doi: 10.3390/ijerph19084425.
PubMed 35457293Boyle SH, Upchurch J, Gifford EJ, Redding TS 4th, Hauser ER, Malhotra D, Press A, Sims KJ, Williams CD. Military exposures and Gulf War illness in veterans with and without posttraumatic stress disorder. J Trauma Stress. 2024 Feb;37(1):80-91. doi: 10.1002/jts.22994. Epub 2023 Nov 23.
PubMed 37997023Thompson AD Jr, Petry SE, Hauser ER, Boyle SH, Pathak GA, Upchurch J, Press A, Johnson MG, Sims KJ, Williams CD, Gifford EJ. Longitudinal Patterns of Multimorbidity in Gulf War Era Veterans With and Without Gulf War Illness. J Aging Health. 2025 Jun;37(5-6):281-291. doi: 10.1177/08982643241245163. Epub 2024 Apr 9.
PubMed 38591766Petry SE, Thompson AD Jr, Hauser ER, Lynch SM, Boyle SH, Upchurch J, Press A, Sims KJ, Williams CD, Gifford EJ. Characterizing Deficit Accumulation Among Gulf War Era Veterans. J Frailty Aging. 2024;13(3):300-306. doi: 10.14283/jfa.2024.44.
PubMed 39082776
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP # 585 - Pilot Study: Gulf War Era Cohort and Biorepository
- ClinicalTrials.gov ID
- NCT01803854
- Acronym / sponsor ID
- CSP# 585 / 585
- Conditions
- Gulf War Era Cohort
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,275 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Sep 2014 (actual)
- Primary completion
- 21 Jul 2019 (actual)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Posted 2 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Asia Johnson at asia.johnson4@va.gov and Christina Williams at christina.williams4@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:
- 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
- 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 survey data, plasma and access to VA and non-VA medical records, 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 Asia Johnson at asia.johnson4@va.gov and Christina Williams at christina.williams4@va.gov
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Veterans who served in the military in 1990-1991 without regard to actual deployment.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Veterans who did not serve in the military in 1990-1991 without regard to actual deployment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VHA Health Care Utilization
Time frame: 20 months
Use of VHA for health care in the past year
Deployment
Time frame: 20 months
Deployment in support of 1990-1991 Gulf War
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30060060Khalil 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.
- Results publication: PubMed 31253242Brown MC, Sims KJ, Gifford EJ, Goldstein KM, Johnson MR, Williams CD, Provenzale D. Gender-based Differences among 1990-1991 Gulf War Era Veterans: Demographics, Lifestyle Behaviors, and Health Conditions. Womens Health Issues. 2019 Jun 25;29 Suppl 1(Suppl 1):S47-S55. doi: 10.1016/j.whi.2019.04.004.
- Results publication: PubMed 34242657Vahey J, Hauser ER, Sims KJ, Helmer DA, Provenzale D, Gifford EJ. Research tool for classifying Gulf War illness using survey responses: Lessons for writing replicable algorithms for symptom-based conditions. Life Sci. 2021 Oct 1;282:119808. doi: 10.1016/j.lfs.2021.119808. Epub 2021 Jul 6.
- Results publication: PubMed 33811897Gifford EJ, Vahey J, Hauser ER, Sims KJ, Efird JT, Dursa EK, Steele L, Helmer DA, Provenzale D. Gulf War illness in the Gulf War Era Cohort and Biorepository: The Kansas and Centers for Disease Control definitions. Life Sci. 2021 Aug 1;278:119454. doi: 10.1016/j.lfs.2021.119454. Epub 2021 Mar 31.
- Results publication: PubMed 34942860Vahey J, Gifford EJ, Sims KJ, Chesnut B, Boyle SH, Stafford C, Upchurch J, Stone A, Pyarajan S, Efird JT, Williams CD, Hauser ER. Gene-Toxicant Interactions in Gulf War Illness: Differential Effects of the PON1 Genotype. Brain Sci. 2021 Nov 25;11(12):1558. doi: 10.3390/brainsci11121558.
- Results publication: PubMed 35457293Gifford EJ, Boyle SH, Vahey J, Sims KJ, Efird JT, Chesnut B, Stafford C, Upchurch J, Williams CD, Helmer DA, Hauser ER. Health-Related Quality of Life by Gulf War Illness Case Status. Int J Environ Res Public Health. 2022 Apr 7;19(8):4425. doi: 10.3390/ijerph19084425.
- Results publication: PubMed 37997023Boyle SH, Upchurch J, Gifford EJ, Redding TS 4th, Hauser ER, Malhotra D, Press A, Sims KJ, Williams CD. Military exposures and Gulf War illness in veterans with and without posttraumatic stress disorder. J Trauma Stress. 2024 Feb;37(1):80-91. doi: 10.1002/jts.22994. Epub 2023 Nov 23.
- Results publication: PubMed 38591766Thompson AD Jr, Petry SE, Hauser ER, Boyle SH, Pathak GA, Upchurch J, Press A, Johnson MG, Sims KJ, Williams CD, Gifford EJ. Longitudinal Patterns of Multimorbidity in Gulf War Era Veterans With and Without Gulf War Illness. J Aging Health. 2025 Jun;37(5-6):281-291. doi: 10.1177/08982643241245163. Epub 2024 Apr 9.
- Results publication: PubMed 39082776Petry SE, Thompson AD Jr, Hauser ER, Lynch SM, Boyle SH, Upchurch J, Press A, Sims KJ, Williams CD, Gifford EJ. Characterizing Deficit Accumulation Among Gulf War Era Veterans. J Frailty Aging. 2024;13(3):300-306. doi: 10.14283/jfa.2024.44.
- An Assessment of Survey Measures Used Across Key Epidemiologic Studies of United States Gulf War I Era VeteransLink provided by the sponsor.
- Click here for more information about this study: CSP # 585 - Pilot Study: Gulf War Era Cohort and BiorepositoryLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Provenzale, MD MS study chair
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gulf War Era Cohort, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VHA Health Care Utilization (time frame: 20 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01803854, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.