Burn Pit ExposurePHOENIXNCT07562243
Project PHOENIX: Molecular Signatures of Burn Pit Exposure
An observational study of Burn Pit Exposure and Airborne Hazard Exposure, run by Creative Medical Technology Holdings Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burn Pit Exposure, Airborne Hazard Exposure, Veteran Health
- What is being tested?
- Prior Burn Pit Exposure and No Known Burn Pit Exposure
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Burn Pit Exposure, Airborne Hazard Exposure, Veteran Health, Deployment-Related Toxic Exposure, Biomarkers, Immune Dysfunction
- Being tested
- Prior Burn Pit Exposure, No Known Burn Pit Exposure
- Keywords
- Burn pit, Airborne hazards, Veterans, Deployment exposure, Multi-omics, PBMC, Biomarker discovery, Transcriptomics, Epigenomics, Proteomics, Metabolomics, Toxic exposure, Military service
- Medical subject headings
- Immune System Diseases, Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prior Burn Pit ExposureOther
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.
No Known Burn Pit ExposureOther
No known deployment-related burn pit exposure based on participant report and available service history.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No Known Burn Pit Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn Pit ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Creative Medical Technology Holdings Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WCG IRB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562243
- Sponsor's protocol ID
- CELZ-BP-OBS-001
- Acronym
- PHOENIX
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular, Genomic, Cellular, and Functional Characterization of Blood Specimens From Former U.S. Service Members With Prior Burn Pit Exposure
- ClinicalTrials.gov ID
- NCT07562243
- Acronym / sponsor ID
- PHOENIX / CELZ-BP-OBS-001
- Conditions
- Burn Pit Exposure, Airborne Hazard Exposure, Veteran Health, Deployment-Related Toxic Exposure, Biomarkers, Immune Dysfunction
- Keywords
- Burn pit, Airborne hazards, Veterans, Deployment exposure, Multi-omics, PBMC, Biomarker discovery, Transcriptomics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Creative Medical Technology Holdings IncIndustry (pharma, biotech, devices)
- Collaborators
- WCG IRB
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prior Burn Pit Exposure | – | Other: Prior Burn Pit ExposureFormer 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 | – | Other: No Known Burn Pit ExposureFormer 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prior Burn Pit ExposureHistory 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. | Other | Prior Burn Pit Exposure |
| No Known Burn Pit ExposureNo known deployment-related burn pit exposure based on participant report and available service history. | Other | Unexposed Control |
Primary outcome
Differential gene expression (RNA-seq normalized counts) between burn pit-exposed and unexposed cohorts
Time frame: Baseline
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.
1 secondary outcome
Association of exposure intensity and duration with biologic measures
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Burn Pit Exposure
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Tele-Exercise for MERP
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Burn Pit Exposure in Veterans: A Cancer Screening Pilot Study at the Inova Saville Cancer Screening & Prevention Center
Cancer
Not yet recruitingPhase 2
Use of Bile Acid Binding Resins to Decrease PFAS Levels Via Colesevalem in Veterans Study
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn Pit Exposure and Airborne Hazard Exposure, run by Creative Medical Technology Holdings Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Creative Medical Technology ((602) 891-8688, kimb@burnpit.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential gene expression (RNA-seq normalized counts) between burn pit-exposed and unexposed cohorts (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.