Project PHOENIX: Molecular Signatures of Burn Pit Exposure (PHOENIX)
27 april 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Observationeel
Inschrijving (Geschat)
1000
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Creative Medical Technology
- Telefoonnummer: (602) 891-8688
- E-mail: kimb@burnpit.ai
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Differential gene expression (RNA-seq normalized counts) between burn pit-exposed and unexposed cohorts
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Association of exposure intensity and duration with biologic measures
Tijdsspanne: Baseline
|
Assessment of relationships between reported exposure duration/intensity and molecular or cellular outcome measures using multivariable analyses.
|
Baseline
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Optional longitudinal change in composite multi-domain health and biomarker score
Tijdsspanne: 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.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 mei 2026
Primaire voltooiing (Geschat)
1 mei 2029
Studie voltooiing (Geschat)
31 december 2031
Studieregistratiedata
Eerst ingediend
16 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
27 april 2026
Eerst geplaatst (Werkelijk)
1 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
1 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
27 april 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CELZ-BP-OBS-001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .