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Completed

NCT Number: NCT02339805

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

next generation sequencing

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)

Device

tumor Assessment tool during the study

Primary outcomes

  1. 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.

Secondary outcomes

  1. Progression free survival

    Time frame: One year

    time between inclusion and progression or relapse or beginning of a new treatment

  2. Overall survival

    Time frame: one year

    time between inclusion and death

  3. Assess the clonal architecture in tumor DNA and bone marrow

    Time frame: one year

  4. 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

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Collaborators

  • U918 ( Inserm unit)

Registry information

Official study title

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

Acronym: LymphoSeq

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jan 15, 2015
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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