Status:
RECRUITING
Characterization and Clinical Impact of the Gut Microbiota in Lymphoma
Lead Sponsor:
Lars Møller Pedersen
Collaborating Sponsors:
Zealand University Hospital
Herlev Hospital
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18+ years
Brief 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 contro...
Detailed Description
Microbiota refers to an ecological community of commensal, symbiotic and pathogenic microorganisms that colonize the various compartments within the human body including the gastrointestinal tract. Th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 6 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06161896
Start Date
May 6 2024
End Date
July 1 2026
Last Update
August 9 2024
Active Locations (1)
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1
Zealand University Hospital, Department of Hematology
Roskilde, Region Sjælland, Denmark, 4000