Examining the gut microbiome in lymphoma patients
Characterization and Clinical Impact of the Gut Microbiota in Diffuse Large B-cell Lymphoma Patients
This study looks at the gut bacteria of newly diagnosed lymphoma patients to see how their treatment and lifestyle might affect their health compared to healthy people.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev Hospital Academic / other |
| Locations | 1 site (Roskilde, Region Sjælland) |
| Trial ID | NCT06161896 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the gut microbiome of newly diagnosed patients with Diffuse Large B-cell Lymphoma (DLBCL) compared to healthy controls. It aims to explore how lymphoma treatment, immune responses, and various lifestyle factors influence the microbiome. The study will analyze stool samples to assess the composition and diversity of gut bacteria and their potential relationship with clinical outcomes and tumor characteristics. The research is conducted in collaboration with multiple clinical and laboratory departments specializing in relevant fields.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed and treatment-naive Diffuse Large B-cell Lymphoma.
Not a fit: Patients with significant gastrointestinal comorbidities or uncontrolled serious infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the gut microbiome's role in lymphoma, potentially leading to improved treatment strategies.
How similar studies have performed: While the connection between gut microbiota and lymphoma is not well understood, similar studies in other cancers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Roskilde, Region Sjælland
- Zealand University Hospital, Department of Hematology — Roskilde, Region Sjælland, Denmark (Recruiting)
Study contacts
- Principal investigator: Christiane Sophie Staxen, MSc — Zealand University Hospital - Roskilde
- Study coordinator: Christiane Sophie Staxen, MSc
- Email: cstax@regionsjaelland.dk
- Phone: +45 22618798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.