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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02339805

Acronym

LymphoSeq

Enrollment

Registered

2015-01-15

Start date

2014-11-01

Completion date

2016-07-31

Last updated

2017-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Hodgkin Lymphoma

Keywords

Minimal residual disease, NGS, NHL, DNA sequencing

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.

Interventions

OTHERnext generation sequencing

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

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

tumor Assessment tool during the study

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—
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	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026