Project PHOENIX: Molecular Signatures of Burn Pit Exposure (PHOENIX)
27. april 2026 oppdatert av: Creative Medical Technology Holdings Inc
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
1000
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Creative Medical Technology
- Telefonnummer: (602) 891-8688
- E-post: kimb@burnpit.ai
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
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.
|
No known deployment-related burn pit exposure based on participant report and available service history.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Differential gene expression (RNA-seq normalized counts) between burn pit-exposed and unexposed cohorts
Tidsramme: 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.
|
Baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Association of exposure intensity and duration with biologic measures
Tidsramme: Baseline
|
Assessment of relationships between reported exposure duration/intensity and molecular or cellular outcome measures using multivariable analyses.
|
Baseline
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Optional longitudinal change in composite multi-domain health and biomarker score
Tidsramme: 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.
|
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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
1. mai 2029
Studiet fullført (Antatt)
31. desember 2031
Datoer for studieregistrering
Først innsendt
16. april 2026
Først innsendt som oppfylte QC-kriteriene
27. april 2026
Først lagt ut (Faktiske)
1. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CELZ-BP-OBS-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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