Project PHOENIX: Molecular Signatures of Burn Pit Exposure

NCT07562243 | Not Yet Recruiting

• 1 other identifier: CELZ-BP-OBS-001
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Burn Pit Exposure; Veteran Health; Deployment-Related Toxic Exposure; Biomarkers; Immune Dysfunction; Respiratory Symptoms; Airborne Hazard Exposure

Keywords

Burn pit; Airborne hazards; Veterans; Deployment exposure; Multi-omics; PBMC; Biomarker discovery; Transcriptomics; Epigenomics; Proteomics; Metabolomics; Toxic exposure; Military service

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Association of exposure intensity and duration with biologic measures

  Baseline

Other Outcomes (1)

• Optional longitudinal change in composite multi-domain health and biomarker score

  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.

Study Arms (2)

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.

Other: Prior Burn Pit Exposure

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.

Other: No Known Burn Pit Exposure

Interventions

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.

Prior Burn Pit Exposure

No Known Burn Pit Exposure OTHER

No known deployment-related burn pit exposure based on participant report and available service history.

Unexposed Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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
• Able and willing to provide informed consent and HIPAA authorization
• Willing to complete study questionnaires and donate venous blood sample
• Able to complete study procedures in English or with approved translation support
• Available for one baseline visit and optional future re-contact, if applicable

You may not qualify if:

• 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
• Hemoglobin less than 10 g/dL, known bleeding disorder, or platelet count less than 100 × 10\^9/L, if known
• Severe psychiatric illness or other condition that impairs ability to provide informed consent
• Prisoner or institutionalized individual
• Prior participation in this or a related Project PHOENIX protocol
• Any other condition that, in the investigator's judgment, may increase risk or interfere with study conduct or data integrity

Sponsors & Collaborators

• WCG IRB: collaborator
• Creative Medical Technology Holdings Inc: lead

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Immune System Diseases; Signs and Symptoms, Respiratory

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Creative Medical Technology

CONTACT

(602) 891-8688; kimb@burnpit.ai

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: May 1, 2026

Record last verified: 2026-04