Project PHOENIX: Molecular Signatures of Burn Pit Exposure (PHOENIX)

Molecular, Genomic, Cellular, and Functional Characterization of Blood Specimens From Former U.S. Service Members With Prior Burn Pit Exposure

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Biomarkers; Respiratory Symptoms; Immune Dysfunction; Burn Pit Exposure; Airborne Hazard Exposure; Veteran Health; Deployment-Related Toxic Exposure
• Intervention / Treatment: Other: Prior Burn Pit Exposure; Other: No Known Burn Pit Exposure

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Creative Medical Technology; Phone Number: (602) 891-8688; Email: kimb@burnpit.ai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; No known deployment-related burn pit exposure based on participant report and available service history.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Creative Medical Technology Holdings Inc
• Collaborators: WCG IRB

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Metabolomics; Veterans; Proteomics; Transcriptomics; Epigenomics; Multi-omics; PBMC; Biomarker discovery; Military service; Burn pit; Airborne hazards; Deployment exposure; Toxic exposure
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Immune System Diseases; Signs and Symptoms, Respiratory
• Other Study ID Numbers: CELZ-BP-OBS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No