Project PHOENIX is an observational clinical research study designed to characterize molecular, genomic, cellular, and functional features in blood specimens from former U.S. Service Members with prior burn pit exposure and from matched unexposed controls. Participants will complete screening, informed consent, health and exposure questionnaires, and a one-time blood collection. Blood-derived specimens may undergo genomic, epigenomic, transcriptomic, proteomic, metabolomic, immunophenotyping, and cellular functional analyses. Participants may also agree to optional future re-contact for health updates and possible repeat blood collection. The goal is to identify biologic signatures associated with prior deployment-related burn pit exposure and to support future biomarker discovery and translational research in veteran health.
Age 18 years or older at the time of consent
Former or current U.S. Service Member, including Active Duty, Reserve, National Guard, or Veteran status
For exposed cohort: prior deployment to a location with known burn pit operations, based on participant report and available confirmation when feasible
For control cohort: no known deployment to burn pit locations
Active serious illness or infection that, in the investigator's judgment, would compromise participation or specimen integrity
Receipt of systemic chemotherapy, immunotherapy, or radiation therapy within the past 6 months
High-dose systemic immunosuppression, defined as more than 20 mg prednisone equivalent daily for more than 14 days within the past 3 months
Pregnant or currently breast-feeding
Former U.S. Service Members and Veterans in the United States, including individuals with prior deployment-related burn pit exposure and comparable unexposed controls. Enrollment will occur through remote screening and consent followed by approved mobile phlebotomy.
Cohort
Prospective
Prior Burn Pit Exposure
Other interventionHistory of deployment-related exposure to environments with known open-air burn pit operations, characterized by self-reported deployment/exposure history and corroborating information when available.
No Known Burn Pit Exposure
Other interventionNo known deployment-related burn pit exposure based on participant report and available service history.
Differential gene expression (RNA-seq normalized counts) between burn pit-exposed and unexposed cohorts
Comparison of whole blood transcriptomic profiles using RNA sequencing. Differential gene expression will be quantified using normalized read counts and modeled as log2 fold-change between cohorts.
Association of exposure intensity and duration with biologic measures
Assessment of relationships between reported exposure duration/intensity and molecular or cellular outcome measures using multivariable analyses.
Optional longitudinal change in composite multi-domain health and biomarker score
A composite score integrating patient-reported outcomes and selected blood-based biomarkers (e.g., inflammatory markers and omics-derived features), summarized as a standardized z-score. Change from baseline will be assessed among participants with follow-up data.
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Creative Medical Technology Holdings Inc
Lead sponsor
WCG IRB
Collaborator
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