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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-01

Study Completion Date

2016-07-31

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

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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.

Conditions

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Non Hodgkin Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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next generation sequencing

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

Group Type EXPERIMENTAL

next generation sequencing

Intervention Type OTHER

DNA from plasma, peripheral blood mononuclear cell and bone marrow will be sequenced by NGS for a panel of 34 genes.

Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)

Intervention Type DEVICE

tumor Assessment tool during the study

Interventions

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next generation sequencing

DNA from plasma, peripheral blood mononuclear cell and bone marrow will be sequenced by NGS for a panel of 34 genes.

Intervention Type OTHER

Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)

tumor Assessment tool during the study

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No