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
Lars Møller Pedersen
200 participants
May 6, 2024
OBSERVATIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria12
- 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 Criteria10
- 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
Interventions
Analysis of microbiome, mutations, alterations in body composition and lifestyle
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06161896