Genomic and Proteomic Study of Richter Syndrome (CGPSR) (CGPSR)
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ClinicalTrials.gov Identifier: NCT03619512 |
Recruitment Status :
Recruiting
First Posted : August 8, 2018
Last Update Posted : March 24, 2023
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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.
Condition or disease | Intervention/treatment |
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Richter Syndrome | Genetic: Whole exome sequencing. Genetic: RNA sequencing Other: Mass spectrometry |
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 |
Estimated Enrollment : | 170 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Genomic and Proteomic Study of Richter Syndrome |
Actual Study Start Date : | September 6, 2017 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | September 5, 2024 |
Group/Cohort | Intervention/treatment |
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Richter Syndrom at diagnosis
patients diagnosed with Richter Syndrom, for whom a suitable lymph node biopsy at diagnosis is available.
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Genetic: Whole exome sequencing.
Retrospective biological exploration of the samples, including tumoral DNA exploration. Genetic: RNA sequencing Characterization of tumor transcriptomic profile. Other: Mass spectrometry Characterization of tumor proteomic profiles. |
Primitive Diffuse Large B-Cell Lymphoma
patients diagnosed with a primitive Large B-Cell Lymphoma, for whom a suitable lymph node biopsy at diagnosis is available.
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Genetic: Whole exome sequencing.
Retrospective biological exploration of the samples, including tumoral DNA exploration. Genetic: RNA sequencing Characterization of tumor transcriptomic profile. Other: Mass spectrometry Characterization of tumor proteomic profiles. |
Other secundary Diffuse Large B-Cell Lymphoma
patients diagnosed with a secundary Large B-Cell Lymphoma (different from Richter Syndrom), for whom a suitable lymph node biopsy at diagnosis is available.
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Genetic: Whole exome sequencing.
Retrospective biological exploration of the samples, including tumoral DNA exploration. Genetic: RNA sequencing Characterization of tumor transcriptomic profile. Other: Mass spectrometry Characterization of tumor proteomic profiles. |
Control group with no tumor involvment of lymph nodes
patients for whom a diagnostic lymph node biopsy has been performed, which did not conclude to any tumoral lymph node involvment.
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Genetic: Whole exome sequencing.
Retrospective biological exploration of the samples, including tumoral DNA exploration. Genetic: RNA sequencing Characterization of tumor transcriptomic profile. Other: Mass spectrometry Characterization of tumor proteomic profiles. |
- Whole exome sequencing data using next generation sequencing method [ Time Frame: 3 years ]
Comparison between the DNA sequences from Richter syndrome samples and DNA sequences from primitive DLBCL samples to identify a set of mutations that are specific to Richter syndrome.
For each position, the result is "mutated" or "unmutated".
- RNA sequencing data using next generation sequencing method [ Time Frame: 3 years ]
Measurment of gene expression for all genes. Comparison of these expression levels between Richter samples, primitive DLBCL samples and normal lymph nodes to identifiy a set of genes which expression levels are different in Richter samples compared primitive DLBCL and normal lymph nodes.
Gene expression is a quatitative value. This set of genes forms a specific "transcriptomic signature" of Richter syndrome.
- Proteomic analysis using mass spectrometry [ Time Frame: 3 years ]
Mass spectrometry allows identification and measurment of the expression level of the 5,000 most expressed proteins in a sample. The investigators want to compare the protein expression levels between Richter samples, primitive DLBCL samples and normal lymph nodes to identifiy a set of proteins that are highly expressed in Richter samples (but not in primitive DLBCL or normal lymph nodes). This set of proteins forms a specific "proteomic signature" of Richter.
Protein expression is a quatitative value expressed as an absolute number of copies in a cell.
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
- 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).
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619512
Contact: Julien Broseus, MD, PhD | + 33 (0)3 83 15 49 14 | j.broseus@chru-nancy.fr | |
Contact: Véronique Saunier | + 33 (0)3 83 15 54 58 | v.saunier@chru-nancy.fr |
France | |
CHRU de Nancy | Recruiting |
Nancy, France, 54035 | |
Contact: Véronique SAUNIER +33 (0)3 83 15 54 58 v.saunier@chru-nancy.fr | |
Principal Investigator: Julien Broséus, MD, PhD | |
Sub-Investigator: Pierre Feugier, MD, PhD |
Principal Investigator: | Julien Broseus, MD, PhD | Central Hospital, Nancy, France | |
Study Director: | Pierre Feugier, MD, PhD | Central Hospital, Nancy, France |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Central Hospital, Nancy, France |
ClinicalTrials.gov Identifier: | NCT03619512 |
Other Study ID Numbers: |
2017-A01978-45 PSS2017/CGPSR-BROSÉUS/VS ( Other Identifier: CHRU Nancy ) |
First Posted: | August 8, 2018 Key Record Dates |
Last Update Posted: | March 24, 2023 |
Last Verified: | March 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Richter Syndrome Genomics Proteomics Chemotherapy resistance |
Syndrome Disease Pathologic Processes |