Actively Recruiting
Characterization and Clinical Impact of the Gut Microbiota in Lymphoma
Led by Lars Møller Pedersen · Updated on 2024-08-09
200
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
Sponsors
L
Lars Møller Pedersen
Lead Sponsor
Z
Zealand University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Characterization and Clinical Impact of the Gut Microbiota in Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed and treatment-naive large B-cell lymphoma (DLBCL) classified by WHO 2022, including: Diffuse large B-cell lymphoma, transformation from 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
- Candidate for R-CHOP-like first-line treatment
- Staging by PET available before treatment starts
- Age 18 years or older
- Written informed consent
You will not qualify if you...
- Pregnancy
- Psychiatric illness or condition impacting understanding of study requirements
- Clinical signs of uncontrolled serious infection
- Clinical gastrointestinal lymphoma involvement
- Significant gastrointestinal comorbidities
- Prior malignancy except non-melanoma skin cancer, stage 0 cervical carcinoma, or low-grade prostate cancer under specific conditions
- Ileostomy
- CNS involvement at diagnosis
- Severe cardiac disease NYHA grade 3-4
- Impaired liver function (transaminases > 3x normal or bilirubin > 1.5x normal) unless due to Gilbert's syndrome
- Renal function GFR < 30 ml/min not caused by lymphoma
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zealand University Hospital, Department of Hematology
Roskilde, Region Sjælland, Denmark, 4000
Actively Recruiting
Research Team
C
Christiane Sophie Staxen, MSc
CONTACT
L
Lars Møller Pedersen, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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