Characterization and Clinical Impact of the Gut Microbiota in Lymphoma

NCT06161896 | Recruiting

• 1 other identifier: MiCheLin
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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 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

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Intestinal microbiota baseline characterization

  Assessment using amplicon-based sequencing of ribosomal (r)RNA genes

  1.5 years

Secondary Outcomes (19)

• Intestinal microbiota characterization at mid-, post-treatment and at follow up

  2.5 years

• Assessment of habitual diet

  2.5 years

• Assessment of energy and macronutrient intake

  2.5 years

• Assessment of physical activity

  2.5 years

• Body composition

  2.5 years

Study Arms (2)

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.

Diagnostic Test: Stool samples

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.

Diagnostic Test: Stool samples

Interventions

Stool samples DIAGNOSTIC_TEST

Analysis of microbiome, mutations, alterations in body composition and lifestyle

Also known as: Blood samples, Bioelectrical impedance analysis, Questionnaires

DLBCL cohort; Healthy control cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include two different cohorts: A: Newly diagnosed and treatment-naïve DLBCL patients B: A healthy control cohort

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lars Møller Pedersen: lead
• Zealand University Hospital: collaborator
• Herlev Hospital: collaborator
• Statens Serum Institut: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Zealand University Hospital, Department of Hematology

Roskilde, Region Sjælland, 4000, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fecal and blood samples

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christiane Sophie Staxen, MSc

  Zealand University Hospital - Roskilde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christiane Sophie Staxen, MSc

CONTACT

+45 22618798; cstax@regionsjaelland.dk

Lars Møller Pedersen, MD, PhD

CONTACT

+45 47324803; lmpn@regionsjaelland.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: December 8, 2023
• Study Start: May 6, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)