Project PHOENIX: Molecular Signatures of Burn Pit Exposure (PHOENIX)
27 kwietnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Obserwacyjny
Zapisy (Szacowany)
1000
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Creative Medical Technology
- Numer telefonu: (602) 891-8688
- E-mail: kimb@burnpit.ai
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
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.
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Differential gene expression (RNA-seq normalized counts) between burn pit-exposed and unexposed cohorts
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Association of exposure intensity and duration with biologic measures
Ramy czasowe: Baseline
|
Assessment of relationships between reported exposure duration/intensity and molecular or cellular outcome measures using multivariable analyses.
|
Baseline
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Optional longitudinal change in composite multi-domain health and biomarker score
Ramy czasowe: 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.
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 maja 2026
Zakończenie podstawowe (Szacowany)
1 maja 2029
Ukończenie studiów (Szacowany)
31 grudnia 2031
Daty rejestracji na studia
Pierwszy przesłany
16 kwietnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
27 kwietnia 2026
Pierwszy wysłany (Rzeczywisty)
1 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
1 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
27 kwietnia 2026
Ostatnia weryfikacja
1 kwietnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CELZ-BP-OBS-001
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Opis planu 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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