Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06161896 |
| Other study ID # |
MiCheLin |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 6, 2024 |
| Est. completion date |
July 1, 2026 |
Study information
| Verified date |
June 2024 |
| Source |
Herlev Hospital |
| Contact |
Christiane Sophie Staxen, MSc |
| Phone |
+45 22618798 |
| Email |
cstax[@]regionsjaelland.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
Description:
Microbiota refers to an ecological community of commensal, symbiotic and pathogenic
microorganisms that colonize the various compartments within the human body including the
gastrointestinal tract. The composition has been shown to play an important role in the
pathophysiology of many diseases as well as influence host homeostatic processes such as
regulation of metabolic processes, defense against pathogens, immune system development,
regulation of the immune response and inflammation. However, the connection between the gut
microbiota and lymphoma remain poorly understood.
The purpose of this study is to evaluate the composition and diversity of the gut microbiome
in a large homogeneous group of patients with newly diagnosed and treatment-naive Diffuse
Large B-cell Lymphoma (DLBCL). The investigators aim to identify the relationship between the
intestinal microbiota, clinical and molecular subtypes of DLBCL and outcome of the disease.
The association between nutrition, physical activity, body composition, toxicity to the
antineoplastic therapy, infections, use of antibiotics, comorbidity and tumor genetics versus
gut microbiota composition and diversity is also explored.
The project is carried out in collaboration between clinical departments, institutes and
laboratories with expertise in microbiology, hematology, pathology, nutrition, molecular
biology, immunology and bioinformatics.
Hypothesis of the study are:
1. Patients with DLBCL have distinct baseline microbiota signatures that differ from
healthy subjects.
2. Significant changes in the microbiota composition and diversity can be identified during
and after treatment (immunochemotherapy) of DLBCL.
3. Lymphoma response and outcome is affected by the composition and diversity of the DLBCL
microbiota.
4. The intestinal microbiota changes towards a microbiota more like the microbiota of
healthy controls in patients who remain in lymphoma remission one year after completion
of therapy.
5. Distinct DLBCL microbiota profiles are associated with treatment-related toxicity.
6. The intestinal microbiota affects the risk of infections (clinically and/or
microbiologically documented).
7. The intestinal microbiota is affected using antibiotics both as prophylaxis and
treatment of infections.
8. The DLBCL microbiota depends on the dietary intake, smoking, physical activity and the
body composition.
9. Distinct intestinal microbiota signatures can be associated with molecular subtypes of
DLBCL (or vice versa)
10. The JAK2V617F, TET2, DNMT3A and ASXL1 mutations affect the intestinal microbiota
signature and are associated with comorbidity and outcome in DLBCL
11. There is a vicious circle between intestinal dysbiosis and lymphoma with the crosstalk
between the gut microbiota and the cancer being expressed as alterations in the profile
of cytokines, chemokines and growth factors; an immune response reflected by
immunophenotypic profiles of peripheral blood mononuclear cells; and characteristic
metabolite signatures in the blood.
