Genomic and Proteomic Study of Richter Syndrome (CGPSR)

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Brief Title

Genomic and Proteomic Study of Richter Syndrome (CGPSR)

Official Title

Genomic and Proteomic Study of Richter Syndrome

Brief Summary

      Biological study on Richter Syndrome (RS), an agressive lymphoma that arises from Chronic
      Lymphocytice Leukemia (CLL). RS presents with the same histological aspect as primitive
      Diffuse Large B-Cell Lymphoma (DLBCL), but is associated with a poor prognosis, due to
      chemorefractoriness.

      This study aims at understanding the biological determinants of chemotherapy resistance in
      Richter Syndrome.
    

Detailed Description

      With the help of the French National Research Group on CLL (FILO / French Innovative Leukemia
      Organization), the investigators are currently gathering fresh frozen cell pellets at CLL
      stage, and lymph node biopsies at Richter stage. The investigators also gathered lymph node
      biopsies from DLBCL, as a reference group.

      The investigators will perform genomic and proteomic comparative studies between CLL and
      Richter, as well as between Richter and primitive DLBCL, to understand the biological
      determinants of clonal evolution and chemorefractoriness of Richter Syndrom.
    


Study Type

Observational


Primary Outcome

Whole exome sequencing data using next generation sequencing method


Condition

Richter Syndrome

Intervention

Whole exome sequencing.

Study Arms / Comparison Groups

 Richter Syndrom at diagnosis
Description:  patients diagnosed with Richter Syndrom, for whom a suitable lymph node biopsy at diagnosis is available.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Genetic

Estimated Enrollment

170

Start Date

September 6, 2017

Completion Date

September 5, 2022

Primary Completion Date

December 31, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of a Diffuse Large B-Cell Lymphoma arising in the context of a Chronic
             Lymphocytic Leukemia (group 1) or diagnosis of a primitive Diffuse Large B-Cell
             Lymphoma (group 2), or diagnosis of a Diffuse Large B-Cell Lymphoma arising in a
             context of small cells lymphoma, excluding CLL (group 3), or benefit from a diagnostic
             lymph node biopsy that did not reveal any tumor involvment (primitive or metastatic)
             (group 4).

          -  Patients must benefit from a lymph node biopsy at diagnosis.

          -  Patients must be followed by a FILO (French Innovative Leukemia Organization) member

          -  Histology of Diffuse Large B-Cell Lymphoma or Hodgkin histology.

          -  Suitable clinical data available.

          -  Samples must meet the following requirement :RIN (RNA Integrity Number) > 5 et DIN
             (DNA Integrity Number) > 6.5.

        Exclusion Criteria:

        • Samples that do not meet the inclusion criteria (insufficient clinical data, analysis
        impossible due to insufficient sample quality).
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Julien Broseus, MD, PhD, + 33 (0)3 83 15 49 14, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT03619512

Organization ID

2017-A01978-45

Secondary IDs

PSS2017/CGPSR-BROSÉUS/VS

Responsible Party

Sponsor

Study Sponsor

Central Hospital, Nancy, France

Collaborators

 French Innovative Leukemia Organization (FILO)

Study Sponsor

Julien Broseus, MD, PhD, Principal Investigator, Central Hospital, Nancy, France


Verification Date

August 2018