Assessment of the Minimal Residual Disease in DLBCL From Cell-free Circulating DNA by NGS

Study Overview
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Brief Summary
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This is a prospective descriptive monocentric study whose purpose is to describe the clonal evolution of the mutational pattern in cfDNA of a cohort of patients with Diffuse Large B-Cell Non-Hodgkin Lymphomas (DLBCL) before, during and after standard treatment

Detailed Description
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To determinate and to describe the clonal evolution, 30 DLBCL cases with available matched tumor DNA and plasma will be collected and analyzed by routinely applicable next generation sequencing (NGS) at the time of diagnosis, at mid treatment, at the end of treatment and at 12 months after diagnosis.

Official Title
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Assessment of the Minimal Residual Disease in Diffuse Large B-Cell Lymphomas (DLBCL) From Cell-free Circulating DNA by Next Generation Sequencing (NGS)

Conditions
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Non Hodgkin Lymphoma

Intervention / Treatment
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* Other: next generation sequencing
* Device: Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age up to 18 years old With a diagnosis formally established of DLBCL or transformed straightaway follicular lymphoma or 3B grade follicular lymphoma or Burkitt-like lymphoma Eligible to a treatment by immunochemotherapy like R-CHOP, R-ACVBP or R-CHOP like First line of treatment Being able to benefit from standard extension assessment ( Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) and bone marrow biopsy with a bone marrow aspiration) Written informed consent Tumor biopsy used for diagnosis available Exclusion Criteria: Patient who cannot receive polychemotherapy like R-CHOP, R-ACVBP, or R-CHOP like Patient who cannot benefit from standard extension assessment and follow-up by with Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) Pregnant or breast-feeding woman Guardianship, curatorship Patient who cannot follow the medical procedures of the study for geographic, social, psychological,linguistic or physical reasons

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: next generation sequencing<br>Determination of clonotypic evolution of the minimal residual disease by next generation sequencing. | Other: next generation sequencing<br>* DNA from plasma, peripheral blood mononuclear cell and bone marrow will be sequenced by NGS for a panel of 34 genes.<br>Device: Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)<br>* tumor Assessment tool during the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the clonal evolution during and after treatment by Next Generation Sequencing | DNA from tumor, DNA from peripheral blood and DNA from bone marrow will be sequencing by NGS for a panel of 34 genes. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | time between inclusion and progression or relapse or beginning of a new treatment | One year | 
| Overall survival | time between inclusion and death | one year | 
| Assess the clonal architecture in tumor DNA and bone marrow |  | one year | 
| Compare the Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) procedure and the kinetic and pattern of somatic mutations identified in cfDNA |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimal residual disease, NGS, NHL, DNA sequencing