Toxin Exposure and Immune Dysregulation in Non-Hodgkin Lymphoma

NCT07652580 | Recruiting

• 2 other identifiers: USUHS.2024-137HU00012520036
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Non-Hodgkin Lymphoma; Lymphoma Non-Hodgkin; B-cell Lymphoma; Immune Dysregulation

Keywords

Immunodeficiency; Lymphoma; Exposure; Genetics

Outcome Measures

Primary Outcomes (3)

• Aim 1: Characterize occupational exposures and their impact on health outcomes and immune health of ADSMs and other MHS beneficiaries with B-cell NHL.

  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.

  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.

  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

Secondary Outcomes (1)

• Exploratory Endpoints

  3 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Uniformed Services University of the Health Sciences: collaborator
• Murtha Cancer Center: collaborator
• Walter Reed National Military Medical Center: collaborator
• United States Naval Medical Center, Portsmouth: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• The American Genome Center: collaborator

Study Sites (3)

Uniformed Services University of the Health Sciences

Bethesda, Maryland, 20814, United States

ACTIVE NOT RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

RECRUITING

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

ACTIVE NOT RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, skin fibroblasts, B-cell NHL tissue and/or bone marrow,

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Immunologic Deficiency Syndromes; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Christin Destefano

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christin B. Destefano, MD, Lt Col, MC, USAF

CONTACT

(301) 295-3190; christin.destefano@usuhs.edu

W. Grant Day, MD, LCDR, MC, USN

CONTACT

(757) 953-2194; william.g.day26.mil@health.mil

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (3)