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

27 aprile 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

1000

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Creative Medical Technology
  • Numero di telefono: (602) 891-8688
  • Email: kimb@burnpit.ai

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Altro: 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.
Altro: No Known Burn Pit Exposure
No known deployment-related burn pit exposure based on participant report and available service history.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Differential gene expression (RNA-seq normalized counts) between burn pit-exposed and unexposed cohorts
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Association of exposure intensity and duration with biologic measures
Lasso di tempo: Baseline
Assessment of relationships between reported exposure duration/intensity and molecular or cellular outcome measures using multivariable analyses.
Baseline

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Optional longitudinal change in composite multi-domain health and biomarker score
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Creative Medical Technology Holdings Inc

Collaboratori

WCG IRB

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 maggio 2029

Completamento dello studio (Stimato)

31 dicembre 2031

Date di iscrizione allo studio

Primo inviato

16 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CELZ-BP-OBS-001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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