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

Not Applicable

Completed

• Conditions: Non Hodgkin Lymphoma
• Interventions: Other: next generation sequencing; Device: Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)

• Registration Number: NCT02339805
• Lead Sponsor: Centre Henri Becquerel

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-11-01
• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-15
• Primary Completion: 2015-07
• Study Completion: 2016-07
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
next generation sequencing	next generation sequencing	Determination of clonotypic evolution of the minimal residual disease by next generation sequencing.
next generation sequencing	Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)	Determination of clonotypic evolution of the minimal residual disease by next generation sequencing.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Progression free survival	One year	time between inclusion and progression or relapse or beginning of a new treatment
Overall survival	one year	time between inclusion and death
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

Trial Locations

Locations (1)

Centre Henri Becquerel; 🇫🇷 Rouen, France