Clinical trial · Observational
Toxin Exposure and Immune Dysregulation in Non-Hodgkin Lymphoma
Toxin Exposure and Immune Dysregulation in Non-Hodgkin Lymphoma Across the Military Healthcare System
NCT07652580CI-TRIAL-00125670TOXNHLrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Immune Dysregulation | — | UNRESOLVED | — |
| Lymphoma Non-Hodgkin | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Cohort 1
- description
- 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.
- label
- Cohort 2
- description
- ADSMs and other MHS beneficiaries ages 18 and older who are newly diagnosed that is untreated or NHL that has been previously treated.
- label
- Cohort 3
- description
- Other MHS beneficiaries ages 4-17 who are newly diagnosed with B-cell NHL or are untreated.
Primary outcomes (3)
- measure
- Aim 1: Characterize occupational exposures and their impact on health outcomes and immune health of ADSMs and other MHS beneficiaries with B-cell NHL.
- timeFrame
- 3 years
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
Show eligibility criteria text
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.
References
Publications (21)
- BACKGROUNDKalia SS, Adelman K, Bale SJ, Chung WK, Eng C, Evans JP, Herman GE, Hufnagel SB, Klein TE, Korf BR, McKelvey KD, Ormond KE, Richards CS, Vlangos CN, Watson M, Martin CL, Miller DT. Recommendations for reporting of secondary findings in clinical exome and genome sequencing, 2016 update (ACMG SF v2.0): a policy statement of the American College of Medical Genetics and Genomics. Genet Med. 2017 Feb;19(2):249-255. doi: 10.1038/gim.2016.190. Epub 2016 Nov 17. PMID 27854360
- BACKGROUNDGonsalves SG, Ng D, Johnston JJ, Teer JK, Stenson PD, Cooper DN, Mullikin JC, Biesecker LG; NISC Comparative Sequencing Program. Using exome data to identify malignant hyperthermia susceptibility mutations. Anesthesiology. 2013 Nov;119(5):1043-53. doi: 10.1097/ALN.0b013e3182a8a8e7. PMID 24195946
- BACKGROUNDJohnston JJ, Rubinstein WS, Facio FM, Ng D, Singh LN, Teer JK, Mullikin JC, Biesecker LG. Secondary variants in individuals undergoing exome sequencing: screening of 572 individuals identifies high-penetrance mutations in cancer-susceptibility genes. Am J Hum Genet. 2012 Jul 13;91(1):97-108. doi: 10.1016/j.ajhg.2012.05.021. Epub 2012 Jun 14. PMID 22703879
- BACKGROUNDNg D, Johnston JJ, Teer JK, Singh LN, Peller LC, Wynter JS, Lewis KL, Cooper DN, Stenson PD, Mullikin JC, Biesecker LG; NIH Intramural Sequencing Center (NISC) Comparative Sequencing Program. Interpreting secondary cardiac disease variants in an exome cohort. Circ Cardiovasc Genet. 2013 Aug;6(4):337-46. doi: 10.1161/CIRCGENETICS.113.000039. Epub 2013 Jul 16. PMID 23861362
- BACKGROUNDRichards S, Aziz N, Bale S, Bick D, Das S, Gastier-Foster J, Grody WW, Hegde M, Lyon E, Spector E, Voelkerding K, Rehm HL; ACMG Laboratory Quality Assurance Committee. Standards and guidelines for the interpretation of sequence variants: a joint consensus recommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology. Genet Med. 2015 May;17(5):405-24. doi: 10.1038/gim.2015.30. Epub 2015 Mar 5. PMID 25741868