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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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)

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 Summary: 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.
Sponsor: Centre Henri Becquerel

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Centre Henri Becquerel

Dates:
Date Received: January 13, 2015
Date Started: November 2014
Date Completion:
Last Updated: October 4, 2016
Last Verified: October 2016