search
Back to results

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

Primary Purpose

Non Hodgkin Lymphoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
next generation sequencing
Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)
Sponsored by
Centre Henri Becquerel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Non Hodgkin Lymphoma focused on measuring Minimal residual disease, NGS, NHL, DNA sequencing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Henri Becquerel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

next generation sequencing

Arm Description

Determination of clonotypic evolution of the minimal residual disease by next generation sequencing.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 13, 2015
Last Updated
July 5, 2017
Sponsor
Centre Henri Becquerel
Collaborators
U918 ( Inserm unit)
search

1. Study Identification

Unique Protocol Identification Number
NCT02339805
Brief Title
Assessment of the Minimal Residual Disease in DLBCL From Cell-free Circulating DNA by NGS
Acronym
LymphoSeq
Official Title
Assessment of the Minimal Residual Disease in Diffuse Large B-Cell Lymphomas (DLBCL) From Cell-free Circulating DNA by Next Generation Sequencing (NGS)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel
Collaborators
U918 ( Inserm unit)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Hodgkin Lymphoma
Keywords
Minimal residual disease, NGS, NHL, DNA sequencing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
next generation sequencing
Arm Type
Experimental
Arm Description
Determination of clonotypic evolution of the minimal residual disease by next generation sequencing.
Intervention Type
Other
Intervention Name(s)
next generation sequencing
Intervention Description
DNA from plasma, peripheral blood mononuclear cell and bone marrow will be sequenced by NGS for a panel of 34 genes.
Intervention Type
Device
Intervention Name(s)
Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)
Intervention Description
tumor Assessment tool during the study
Primary Outcome Measure Information:
Title
Determine the clonal evolution during and after treatment by Next Generation Sequencing
Description
DNA from tumor, DNA from peripheral blood and DNA from bone marrow will be sequencing by NGS for a panel of 34 genes.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Progression free survival
Description
time between inclusion and progression or relapse or beginning of a new treatment
Time Frame
One year
Title
Overall survival
Description
time between inclusion and death
Time Frame
one year
Title
Assess the clonal architecture in tumor DNA and bone marrow
Time Frame
one year
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice Jardin, Professor
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26883583
Citation
Camus V, Sarafan-Vasseur N, Bohers E, Dubois S, Mareschal S, Bertrand P, Viailly PJ, Ruminy P, Maingonnat C, Lemasle E, Stamatoullas A, Picquenot JM, Cornic M, Beaussire L, Bastard C, Frebourg T, Tilly H, Jardin F. Digital PCR for quantification of recurrent and potentially actionable somatic mutations in circulating free DNA from patients with diffuse large B-cell lymphoma. Leuk Lymphoma. 2016 Sep;57(9):2171-9. doi: 10.3109/10428194.2016.1139703. Epub 2016 Feb 17.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs