Clinical trial NCT03619512: Genomic and Proteomic Study of Richter Syndrome (CGPSR)
Official title: Genomic and Proteomic Study of Richter Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Richter Syndrome
Keywords: Richter Syndrome
Genomics
Proteomics
Chemotherapy resistance
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: French Innovative Leukemia Organization (FILO)
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2018-08-08
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Diagnosis of Diffuse Large B-Cell Lymphoma arising in the context of a Chronic Lymphocytic Leukemia (group 1).
* Diagnosis of Diffuse Large B-Cell Lymphoma de novo (group 2).
* Diagnosis of Diffuse Large B-Cell Lymphoma arising in a context of small cells lymphoma, excluding CLL (group 3).
* Patients who benefited from a diagnostic lymph node biopsy that did not reveal any tumor involvment (primitive or metastatic) (group 4).

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.

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).

Primary outcomes:
measure: Whole exome sequencing data using next generation sequencing method
timeFrame: 3 years
measure: RNA sequencing data using next generation sequencing method
timeFrame: 3 years
measure: Proteomic analysis using mass spectrometry
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Julien Broseus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Hospital, Nancy, France
name: Pierre Feugier, MD, PhD
role: STUDY_DIRECTOR
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