Project PHOENIX: Molecular Signatures of Burn Pit Exposure (PHOENIX)
27. april 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
1000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Creative Medical Technology
- Telefonnummer: (602) 891-8688
- E-mail: kimb@burnpit.ai
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. maj 2026
Primær færdiggørelse (Anslået)
1. maj 2029
Studieafslutning (Anslået)
31. december 2031
Datoer for studieregistrering
Først indsendt
16. april 2026
Først indsendt, der opfyldte QC-kriterier
27. april 2026
Først opslået (Faktiske)
1. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. april 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CELZ-BP-OBS-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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