Characterization and Clinical Impact of the Gut Microbiota in Diffuse Large B-cell Lymphoma Patients

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• 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

Locations
Other Locations
Denmark
Zealand University Hospital, Department of Hematology
RECRUITING
Roskilde
Contact Information
Primary
Christiane Sophie Staxen, MSc
cstax@regionsjaelland.dk
+45 22618798
Backup
Lars Møller Pedersen, MD, PhD
lmpn@regionsjaelland.dk
+45 47324803
Time Frame
Start Date: 2024-05-06
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 200
Treatments
DLBCL cohort
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.
Healthy control cohort
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.
Sponsors
Collaborators: Weill Medical College of Cornell University, Zealand University Hospital, Statens Serum Institut, Herlev Hospital
Leads: Lars Møller Pedersen

This content was sourced from clinicaltrials.gov