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Toxin Exposure and Immune Dysregulation in Non-Hodgkin Lymphoma (TOXNHL)

11. juni 2026 opdateret af: Henry M. Jackson Foundation for the Advancement of Military Medicine

Toxin Exposure and Immune Dysregulation in Non-Hodgkin Lymphoma Across the Military Healthcare System

The goal of this observational cohort study is to learn how toxin and occupational exposures, germline genetic variation, and immune dysregulation relate to B-cell non-Hodgkin lymphoma among active-duty service members and other Military Health System beneficiaries. The main questions are whether specific exposures and germline variants are associated with B-cell NHL subtype, immune dysfunction, and clinical outcomes. Participants will complete exposure and medical-history surveys, provide biospecimens for immune and genomic testing, and may be followed annually for up to 3 years.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

This prospective observational registry and biorepository study evaluates the relationship between occupational/environmental toxin exposures, immune dysregulation, and germline genetic susceptibility in active-duty service members (ADSMs) and other Military Health System (MHS) beneficiaries with B-cell non-Hodgkin lymphoma (NHL). Participants will be enrolled into one of three cohorts based on disease status and age, including individuals in remission, newly diagnosed adults, and treatment-naïve pediatric patients.

The study will collect clinical, epidemiologic, immunologic, and genomic data longitudinally for up to 3 years. Participants will complete standardized surveys assessing demographics, military history, occupational/environmental exposures, medical history, and family history. Additional military exposure data may be obtained from the Department of Defense Individual Longitudinal Exposure Record (ILER).

Clinical data abstracted from the electronic medical record will include lymphoma subtype, staging, pathology, treatment history, laboratory values, infectious complications, immune phenotyping, treatment response, recurrence, second malignancies, and survival outcomes.

Biospecimens may include peripheral blood, skin fibroblasts, residual tumor tissue, bone marrow aspirate, and archived serum samples from the Department of Defense Serum Repository (DODSR). Germline and somatic genomic analyses will be performed using next-generation sequencing platforms, including whole genome sequencing. Immunologic analyses may include lymphocyte subsets, B-cell phenotyping, T-cell phenotyping, activation markers, cytokine profiling, and functional immune assays.

The primary objectives are to characterize toxin exposures and immune dysregulation in B-cell NHL, identify germline pathogenic variants associated with lymphoma susceptibility, and establish a comprehensive longitudinal database and biospecimen repository for future translational research. Exploratory analyses will evaluate relationships among environmental exposures, genomic variants, immune phenotypes, lymphoma subtype, and clinical outcomes.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20814
        • Rekruttering
        • Walter Reed National Military Medical Center
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Jeremy Perkins, MD, FACP, COL, US Army (ret)
      • Bethesda, Maryland, Forenede Stater, 20814
        • Aktiv, ikke rekrutterende
        • Uniformed Services University of the Health Sciences
    • Virginia
      • Portsmouth, Virginia, Forenede Stater, 23708
        • Aktiv, ikke rekrutterende
        • Naval Medical Center Portsmouth

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Active-duty service members and other MHS beneficiaries, ages 4 years old and up, with B-cell NHL recruited from WRNMMC/Murtha Cancer Center, adult/pediatric Hematology-Oncology clinics, Allergy/Immunology clinic, screening from existing clinical patient lists, and associated MHS sites.

Beskrivelse

Inclusion Criteria:

  • Age 4 years old and older with a clinical diagnosis of B-cell NHL.
  • Must be willing to undergo phlebotomy and/or skin punch biopsy.
  • Must be willing to undergo whole genome sequencing, which includes return of primary and secondary findings.

Exclusion Criteria:

  • Has any condition that, in the opinion of the Principal Investigator, contraindicates participation in this study. Examples of situation that may contraindicate participation include but are not limited to a) some cases of cerebral vascular accidents where an individual no longer has the capacity to make their own medical decisions and a conservator or responsible family member is not available and b) an individual has active suicidal ideation and is a danger to themselves at the time of enrollment.
  • Does not have access to health care and primary care clinician.
  • Actively undergoing induction treatment for NHL.

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
Cohort 1
Active duty service members (ADSMs) and other Military Health System (MHS) beneficiaries who have a history of B-cell non-Hodgkin Lymphoma (NHL) and have achieved clinical remission.
Cohort 2
ADSMs and other MHS beneficiaries ages 18 and older who are newly diagnosed with B-cell NHL and/or are not undergoing active treatment.
Cohort 3
Other MHS beneficiaries ages 4-17 who are diagnosed with B-cell NHL and are treatment naive.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Aim 1: Characterize occupational exposures and their impact on health outcomes and immune health of ADSMs and other MHS beneficiaries with B-cell NHL.
Tidsramme: 3 years
  1. Characterize and determine the prevalence of various toxin and occupational exposures in ADSMs and other MHS beneficiaries with B-cell NHL (Cohorts 1-3).
  2. Characterize the B-cell NHL subtypes and health outcomes of NHL in ADSMs and other MHS beneficiaries (Cohorts 1-3).
  3. Characterize immune dysregulation in ADSMs and other MHS beneficiaries with B-cell NHL. Immune dysregulation could be characterized by humoral vs cellular defects as well as innate vs adaptive defects among others (Cohorts 2-3).
3 years
Aim 2: Identify and interpret germline variants in ADSMs and other MHS beneficiaries with B-cell NHL.
Tidsramme: 3 years
1. Determine the relative frequency of germline pathogenic/likely pathogenic variants in MHS beneficiaries with B-cell NHL (Cohorts 1-3).
3 years
Aim 3: Create a comprehensive database and biorepository of ADSMs and other MHS beneficiaries with B-cell NHL.
Tidsramme: 3 years
  1. Create a database compiling clinical information, toxin exposure, military history (if applicable), and health outcomes (Cohorts 1-3).
  2. Create a biorespository of peripheral blood (Cohorts 1-3).
3 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exploratory Endpoints
Tidsramme: 3 years
  1. Determine the relative frequency of somatic tumor mutations in MHS beneficiaries and analyze the association with germline variants (Cohorts 1-3).
  2. Characterize pre-diagnostic serum of ADSMs and analyze their association with clinical outcomes, tumor subtype, and subsequent immune dysregulation.
3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Samarbejdspartnere

Children's Hospital Medical Center, Cincinnati
Walter Reed National Military Medical Center
Uniformed Services University of the Health Sciences
United States Naval Medical Center, Portsmouth
Murtha Cancer Center
The American Genome Center

Efterforskere

  • Ledende efterforsker: Christin Destefano, Uniformed Services University of the Health Sciences

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

1. maj 2025

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

11. juni 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • USUHS.2024-137
  • HU00012520036 (Andet bevillings-/finansieringsnummer: Uniformed Services University of the Health Sciences)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Coded/de-identified study data and biospecimen-associated data may be shared with approved collaborators or public/controlled repositories using external study/sample IDs and appropriate data-sharing agreements; direct identifiers will not be shared. Data shared via cBioPortal as well as by formal request with appropriate agreements in place.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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