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| Name | Class |
|---|---|
| WCG IRB | OTHER |
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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.
Open-air burn pits used during military operations in Southwest Asia and other deployment settings have been associated with complex airborne exposures and long-term health concerns, including respiratory, cardiovascular, neurologic, immune, and oncologic sequelae. Prior studies have relied largely on self-report, clinical symptoms, or limited physiologic testing, and there remains a need for objective biologic markers of exposure-associated effects. Project PHOENIX is intended to generate a standardized, high-dimensional biospecimen and data resource that can support biomarker discovery, mechanistic modeling, and future translational research.
Participants will enroll remotely. Screening, consent, and questionnaire completion will occur electronically through a secure eConsent platform. After consent, participants will complete a baseline study visit that includes eligibility confirmation, collection of demographic and exposure history and venipuncture.
The exposed cohort will include former U.S. Service Members with prior deployment to locations with known burn pit operations. The control cohort will include comparable U.S. Service Members/Veterans without known burn pit deployment exposure. Planned analyses include between-group comparisons across multi-omic and cellular-function domains, assessment of exposure intensity/duration relationships, and development of integrated predictive models using statistical and machine-learning methods. Optional annual re-contact for up to 5 years may be used to update health status and obtain additional blood specimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prior Burn Pit Exposure | Former U.S. Service Members with prior deployment to locations with known burn pit operations, based on self-report and available service/registry confirmation when feasible. Participants will complete study questionnaires, brief health assessments, and one-time blood collection for multi-omic, cellular, and functional analyses. Optional future re-contact may occur. |
| |
| Unexposed Control | Former U.S. Service Members/Veterans without known deployment-related burn pit exposure, frequency-matched at the group level to the exposed cohort on selected demographic/service characteristics. Participants will complete study questionnaires, brief health assessments, and one-time blood collection for comparative analyses. Optional future re-contact may occur. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prior Burn Pit Exposure | Other | History 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Exploratory follow-up of health status updates and, where applicable, repeat blood-based measures among participants who consent to longitudinal re-contact. Baseline and annually up to 60 months. |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Creative Medical Technology | Contact | (602) 891-8688 | kimb@burnpit.ai |
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De-identified data and associated metadata may be shared in the future with qualified investigators under sponsor governance, applicable IRB approval, and data use agreements, consistent with participant consent and applicable privacy requirements.
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| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Whole blood, buffy coat/DNA-RNA fractions, PBMC aliquots, plasma/serum aliquots, and quality-control aliquots will be collected and retained. Biospecimens may be used for genomic, epigenomic, transcriptomic, proteomic, metabolomic, immunophenotyping, and cellular functional studies.
| No Known Burn Pit Exposure | Other | No known deployment-related burn pit exposure based on participant report and available service history. |
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