Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161896
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2023-11-15
Brief Title:
Characterization and Clinical Impact of the Gut Microbiota in Lymphoma
Sponsor:
Lars Møller Pedersen
Organization:
Herlev Hospital
Study Overview
Official Title:
Characterization and Clinical Impact of the Gut Microbiota in Diffuse Large B-cell Lymphoma Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None