Clinical trial · Observational
Characterization and Clinical Impact of the Gut Microbiota in Lymphoma
Characterization and Clinical Impact of the Gut Microbiota in Diffuse Large B-cell Lymphoma Patients
NCT06161896CI-TRIAL-00079616unknownClinicalTrials.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 study is a prospective observational single-center cohort study which compare the gut microbiome of newly diagnosed Diffuse Large B-cell Lymphoma patients with the gut microbiome of healthy controls. Furthermore the impact of lymphoma treatment, immune phenotypes, cytokine profiles, metabolomics, inflammation, driver mutations, comorbidity, body composition and lifestyle on the microbiome is also investigated
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stool samples | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- DLBCL cohort
- description
- Interventions for the DLBCL cohort are: * Fecal samples * Blood samples * Bioelectrical impedance analyses * Filling in questionnaires All other procedures will be in accordance with local and national guidelines corresponding to clinical standard care.
- interventionNames
- Diagnostic Test: Stool samples
- label
- Healthy control cohort
- description
- The control group applied in the current study is based on the Danish General Suburban Population Study (GESUS). The control subjects are selected from the GESUS cohort and matched according to age and gender. Serial stool samples are planned in a subset of the control cohort with sampling time points corresponding to the DLBCL cohort. The sample material is handled and stored the same way as for the DLBCL cohort.
- interventionNames
- Diagnostic Test: Stool samples
Primary outcomes (1)
- measure
- Intestinal microbiota baseline characterization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for the DLBCL cohort: * WHO 2022 classified newly diagnosed and treatment-naïve large B-cell lymphoma (DLBCL) belonging to one of the following entities: * Diffuse large B-cell lymphoma, including transformation from an indolent lymphoma * Follicular lymphoma grade 3B * T-cell/histiocyte-rich LBCL * Primary cutaneous DLBCL, leg type * EBV-positive DLBCL, NOS * Primary mediastinal LBCL * High grade B-cell lymphoma with MYC/BCL2 rearrangement * The patient is a candidate for R-CHOP-like first-line treatment * Staging by PET available before treatment initiation * Age ≥18 years * Written informed consent Exclusion Criteria for the DLBCL cohort: * Pregnancy * Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study * Clinical signs of uncontrolled serious infection * Clinical gastrointestinal lymphoma involvement * Other significant gastrointestinal comorbidities * Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ), cervical carcinoma, unless treated with curative intent, and without relapse for 2 years, or low-grade prostate cancer, not in need of treatment * Ileostomy * CNS involvement at diagnosis * Severe cardiac disease: NYHA grade 3-4 * Impaired liver (transaminases \> 3 x normal upper limit or bilirubin \> 1.5 x normal upper limit, unless due to Gilbert´s syndrome) or renal (GFR\<30ml/min) function not caused by lymphoma
References
Publications (0)
Data not yet available
No reference posted for this study.