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

July 5, 2017 updated by: Centre Henri Becquerel

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

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

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76038
        • Centre Henri Becquerel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the clonal evolution during and after treatment by Next Generation Sequencing
Time Frame: 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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: One year
time between inclusion and progression or relapse or beginning of a new treatment
One year
Overall survival
Time Frame: one year
time between inclusion and death
one year
Assess the clonal architecture in tumor DNA and bone marrow
Time Frame: one year
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
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Henri Becquerel

Collaborators

U918 ( Inserm unit)

Investigators

  • Principal Investigator: Fabrice Jardin, Professor, Centre Henri Becquerel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 14, 2015

First Posted (Estimate)

January 15, 2015

Study Record Updates

Last Update Posted (Actual)

July 7, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHB13.03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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