Toxin Exposure and Immune Dysregulation in Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4+
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 3 trial groupsGroup A: Cohort 1
Group B: Cohort 2
Group C: Cohort 3
Trial outcomes
Primary outcomes
1
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).
Time frame
3 years2
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).
Time frame
3 years3
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).
Time frame
3 yearsSecondary outcomes
1
Exploratory Endpoints
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.
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead sponsor
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
Source ClinicalTrials.gov