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

Non Hodgkin Lymphoma Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339805
• Other study ID #: CHB13.03
• Status: Completed
• Phase: N/A
• First received: January 13, 2015
• Last updated: July 5, 2017
• Start date: November 1, 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2017
• Source: Centre Henri Becquerel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Neoplasm, Residual
• Non Hodgkin Lymphoma

Intervention

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

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
Centre Henri Becquerel	U918 ( Inserm unit)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year
Secondary	Progression free survival	time between inclusion and progression or relapse or beginning of a new treatment	One year
Secondary	Overall survival	time between inclusion and death	one year
Secondary	Assess the clonal architecture in tumor DNA and bone marrow		one year
Secondary	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