Diffuse Large B Cell LymphomaNCT06161896
Characterization and Clinical Impact of the Gut Microbiota in Lymphoma
An observational study of Diffuse Large B Cell Lymphoma, run by Lars Møller Pedersen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Stool samples
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 6 May 2024to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include two different cohorts: A: Newly diagnosed and treatment-naïve DLBCL patients B: A healthy control cohort
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Zealand University Hospital, Department of Hematology
Roskilde, Region Sjælland, 4000
Lars Møller Pedersen, MD, +45 47324803, lmpn@regionsjaelland.dk
Christiane Sophie Staxen, MSc, cstax@regionsjaelland.dk
About this study
Official title: Characterization and Clinical Impact of the Gut Microbiota in Diffuse Large B-cell Lymphoma Patients
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
Read the 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:
- Patients with DLBCL have distinct baseline microbiota signatures that differ from healthy subjects.
- Significant changes in the microbiota composition and diversity can be identified during and after treatment (immunochemotherapy) of DLBCL.
- Lymphoma response and outcome is affected by the composition and diversity of the DLBCL microbiota.
- 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.
- Distinct DLBCL microbiota profiles are associated with treatment-related toxicity.
- The intestinal microbiota affects the risk of infections (clinically and/or microbiologically documented).
- The intestinal microbiota is affected using antibiotics both as prophylaxis and treatment of infections.
- The DLBCL microbiota depends on the dietary intake, smoking, physical activity and the body composition.
- Distinct intestinal microbiota signatures can be associated with molecular subtypes of DLBCL (or vice versa)
- The JAK2V617F, TET2, DNMT3A and ASXL1 mutations affect the intestinal microbiota signature and are associated with comorbidity and outcome in DLBCL
- 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.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Stool samples
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool samplesDiagnostic test
Also called Blood samples, Bioelectrical impedance analysis, Questionnaires
Analysis of microbiome, mutations, alterations in body composition and lifestyle
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal microbiota baseline characterization
Assessment using amplicon-based sequencing of ribosomal (r)RNA genes
Measured: 1.5 years
Secondary outcomes (19)
Intestinal microbiota characterization at mid-, post-treatment and at follow up
Assessment using amplicon-based sequencing of ribosomal (r)RNA genes
Measured: 2.5 years
Assessment of habitual diet
Food frequency questionnaire (FFQ)
Measured: 2.5 years
Assessment of energy and macronutrient intake
24h dietary recalls
Measured: 2.5 years
Assessment of physical activity
International physical activity questionnaire (IPAQ)
Measured: 2.5 years
Body composition
Body composition according to bioelectrical impedance analysis (BIA) using BioScan touch i8 - IVF version
Measured: 2.5 years
Smoking
Packages (baseline lifestyle questionnaire)
Measured: 2.5 years
Alcohol intake
Units (baseline lifestyle questionnaire)
Measured: 2.5 years
Treatment-related toxicity
Treatment-related toxicity (CTCAE criteria)
Measured: 1.5 years
Antibiotics
Use of any type of prophylactic and therapeutic antibiotics during treatment (baseline lifestyle questionnaire)
Measured: 1.5 years
Statins
Use of any type of statins during treatment registered in the Shared Medication Record (FMK)
Measured: 1.5 years
Medication
Use of any type of medication registered in the Shared Medication Record (FMK)
Measured: 1.5 years
Infections
Clinical infections during treatment
Measured: 1.5 years
Lymphoma response
Lymphoma response after completion of first line treatment (Lugano criteria)
Measured: 1.5 years
Molecular signatures
Molecular signatures in standard clinical practice according to Hans classification (cell of origin (COO))
Measured: 1.5 years
Chromosome abnormalities
Molecular signatures in standard clinical practice (fluorescent in situ hybridization (FISH))
Measured: 1.5 years
Mutations
JAK2V617F, TET2, DNMT3A and ASXL1 mutation analyses (%VAF)
Measured: 1.5 years
Cytokine profiles
Magnetic bead-based assays
Measured: 1.5 years
Metabolite signatures
Metabolomic profiling by a combination of GC and LC coupled with MS
Measured: 1.5 years
Peripheral blood mononuclear cell (PBMC) profiles
PBMC profiles according to flow cytometry
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start6 May 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lars Møller Pedersen
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital, Herlev Hospital, Statens Serum Institut, Weill Medical College of Cornell University
- Responsible party
- Sponsor-investigator, Lars Møller Pedersen, Herlev Hospital
- Investigators
- Christiane Sophie Staxen, MSc, Principal investigator, Zealand University Hospital - Roskilde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161896
- Sponsor's protocol ID
- MiCheLin
- Status last verified
- Aug 2024
- First submitted
- 15 Nov 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Clinical Impact of the Gut Microbiota in Diffuse Large B-cell Lymphoma Patients
- ClinicalTrials.gov ID
- NCT06161896
- Acronym / sponsor ID
- MiCheLin
- Conditions
- Diffuse Large B Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lars Møller PedersenUniversity, hospital or other
- Collaborators
- Zealand University Hospital, Herlev Hospital, Statens Serum Institut, Weill Medical College of Cornell University
- Study start
- 6 May 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients with DLBCL have distinct baseline microbiota signatures that differ from healthy subjects.
- Significant changes in the microbiota composition and diversity can be identified during and after treatment (immunochemotherapy) of DLBCL.
- Lymphoma response and outcome is affected by the composition and diversity of the DLBCL microbiota.
- 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.
- Distinct DLBCL microbiota profiles are associated with treatment-related toxicity.
- The intestinal microbiota affects the risk of infections (clinically and/or microbiologically documented).
- The intestinal microbiota is affected using antibiotics both as prophylaxis and treatment of infections.
- The DLBCL microbiota depends on the dietary intake, smoking, physical activity and the body composition.
- Distinct intestinal microbiota signatures can be associated with molecular subtypes of DLBCL (or vice versa)
- The JAK2V617F, TET2, DNMT3A and ASXL1 mutations affect the intestinal microbiota signature and are associated with comorbidity and outcome in DLBCL
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DLBCL cohort | – | Diagnostic Test: Stool samplesInterventions 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. |
| Healthy control cohort | – | Diagnostic Test: Stool samplesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include two different cohorts: A: Newly diagnosed and treatment-naïve DLBCL patients B: A healthy control cohort
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool samplesAlso: Blood samples, Bioelectrical impedance analysis, QuestionnairesAnalysis of microbiome, mutations, alterations in body composition and lifestyle | Diagnostic test | DLBCL cohort, Healthy control cohort |
Primary outcome
Intestinal microbiota baseline characterization
Time frame: 1.5 years
Assessment using amplicon-based sequencing of ribosomal (r)RNA genes
19 secondary outcomes
Intestinal microbiota characterization at mid-, post-treatment and at follow up
Time frame: 2.5 years
Assessment of habitual diet
Time frame: 2.5 years
Assessment of energy and macronutrient intake
Time frame: 2.5 years
Assessment of physical activity
Time frame: 2.5 years
Body composition
Time frame: 2.5 years
Smoking
Time frame: 2.5 years
Alcohol intake
Time frame: 2.5 years
Treatment-related toxicity
Time frame: 1.5 years
Antibiotics
Time frame: 1.5 years
Statins
Time frame: 1.5 years
Medication
Time frame: 1.5 years
Infections
Time frame: 1.5 years
Lymphoma response
Time frame: 1.5 years
Molecular signatures
Time frame: 1.5 years
Chromosome abnormalities
Time frame: 1.5 years
Mutations
Time frame: 1.5 years
Cytokine profiles
Time frame: 1.5 years
Metabolite signatures
Time frame: 1.5 years
Peripheral blood mononuclear cell (PBMC) profiles
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane Sophie Staxen, MSc principal investigator
Zealand University Hospital - Roskilde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B Cell Lymphoma, run by Lars Møller Pedersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christiane Sophie Staxen, MSc (+45 22618798, cstax@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal microbiota baseline characterization (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.