RECRUITING

Validating Gulf War Illness Blood Biomarkers

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators goals are to identify blood lipids/metabolites that correlate with cognitive decline in the presence of the APOE ε4 allele among veterans with GWI. To determine the effect of dietary, medical and biological factors that influence lipid and metabolites in blood from GW veterans. To identify blood lipid/metabolite profiles that correlate with bioenergetics deficits and glial activation in the brains of GWI. To validate blood biomarker signatures of GWI using APOE genotyping and blood lipids/metabolites that correlate with the CNS dysfunction in GWI.

Official Title

Validating Blood Biomarkers of Brain Immune and Metabolic Dysfunction in Gulf War Illness

Quick Facts

Study Start:2022-06-30
Study Completion:2026-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05736146

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 35 years or older.
  2. 2. For GWI cases, served in the 1990-1991 Gulf War as active duty, national guard, or reserves and meet criteria for the CDC Chronic Multisymptom Illness (CMI) GWI definition or Kansas GWI definition.
  3. 3. For controls, must be a veteran in the same age range as those veterans with GWI as defined above.
  4. 4. Ability to understand written and spoken English or availability of a legal representative who can understand written or spoken English. Participants and caregiver/informants must be able to read, write and speak the language in which psychometric tests are provided with visual and auditory acuity (corrected) sufficient to allow for accurate testing.
  1. 1. Diagnosed or being treated by a physician for any of the following (Steele et al, 2000) and deemed clinically significant per the discretion of the PI:
  2. 1. Cancer (except for non-melanoma skin cancers)
  3. 2. Chronic infectious disease
  4. 3. Problems resulting from postwar injuries.
  5. 4. Liver disease
  6. 5. Lupus
  7. 6. Multiple sclerosis
  8. 7. Stroke
  9. 8. Serious psychiatric condition (those associated with psychosis and/or for which the respondent had been hospitalized since 1991).
  10. 9. Dementia or any type of Parkinson's disease (PD).
  11. 2. Hospitalized in the last 5 years for alcohol or drug dependence, depression, or post-traumatic stress disorder (PTSD).
  12. 3. Female subject is either pregnant or nursing.

Contacts and Locations

Study Contact

Dakota Helgager, B.S
CONTACT
(941) - 256 - 8019
dhelgager@roskampclinic.org

Principal Investigator

Laila Abdullah, Ph.D.
PRINCIPAL_INVESTIGATOR
The Roskamp Institute
Michael Hoffmann, MD
PRINCIPAL_INVESTIGATOR
The Roskamp Institute
Kim Sullivan, Ph.D
PRINCIPAL_INVESTIGATOR
Boston University
Maheen Adamson, Ph.D.
PRINCIPAL_INVESTIGATOR
Palo Alto Veterans Institute of Research

Study Locations (Sites)

Palto Alto Veterans Institute for Research
Palo Alto, California, 94304
United States
The Roskamp Institute
Sarasota, Florida, 34232
United States
Boston University
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Roskamp Institute Inc.

  • Laila Abdullah, Ph.D., PRINCIPAL_INVESTIGATOR, The Roskamp Institute
  • Michael Hoffmann, MD, PRINCIPAL_INVESTIGATOR, The Roskamp Institute
  • Kim Sullivan, Ph.D, PRINCIPAL_INVESTIGATOR, Boston University
  • Maheen Adamson, Ph.D., PRINCIPAL_INVESTIGATOR, Palo Alto Veterans Institute of Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-30
Study Completion Date2026-03-01

Study Record Updates

Study Start Date2022-06-30
Study Completion Date2026-03-01

Terms related to this study

Keywords Provided by Researchers

  • Gulf War
  • APOE

Additional Relevant MeSH Terms

  • Gulf War Syndrome
  • Gulf War Illness