Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06161896

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Zealand University Hospital, Department of Hematology

Roskilde, Region Sjælland, Denmark, 4000

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here