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Molecular Prognosis of Lymphomas of the Central Nervous System (ALYCE-molecular) (ALYCEmolecular)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859544
Recruitment Status : Unknown
Verified February 2019 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:

Central nervous system lymphoma (PCNSL) is a diffuse large B cell lymphoma (DLBCL) entity with a particularly poor prognosis (median survival less than 3 years). They are still poorly characterized biologically, largely because of their rarity (300 cases / year in France) and the difficulty for obtaining a material of sufficient quality and quantity. It is nevertheless assumed that their pathophysiology is particular, since they develop exclusively in an immunological sanctuary, and that they present some characteristic molecular abnormalities (mutation of MYD88 or TBL1XR1 for example).

A collection of 74 PCNSLs has created, clinically annotated, from which frozen material is available in addition to the material fixed and included in paraffin (cohort ALYCE). Informed consent was gathered for all patients. Comparative Genomic Hybridization-array analysis of this cohort has already revealed abnormalities associated with a poor prognosis (unpublished data). The objective of this study is to complete this analysis by sequencing a panel of 96 mutant genes recurrently in DLBCLs and PCNSLs, and the molecular determination of the original cell by the (RT-MLPA) Reverse Transcriptase-Multiplex Ligation-dependent Probe Amplification technique.

The integration of genetic, molecular and transcriptomic data may define prognostic markers and open perspectives for translational research in PCNSL.


Condition or disease Intervention/treatment
Central Nervous System Lymphoma Other: Retrospective study

Study Design
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Study Type : Observational
Estimated Enrollment : 74 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Molecular Prognosis of Lymphomas of the Central Nervous System (ALYCE-molecular)
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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Intervention Details:
  • Other: Retrospective study
    Retrospective study to search mutations associated with Central nervous system lymphoma and study of the prognostic impact (overall survival and progression-free survival) of these mutations.

Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: Up to 48 months ]
    Analysis of progression-free survival correlated with genomic data and mutation data


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
This study focuses on adult subjects (male and female) with central nervous system lymphoma.
Criteria

Inclusion Criteria:

  • Adults
  • With a lymphoma of the central nervous system
  • Patients having signed the consent for the conservation of their samples within the cohort

Exclusion Criteria:

  • <18 old years
  • Other diagnosis than lymphoma of the central nervous system
  • No consent form signed
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03859544


Contacts
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Contact: Hervé GHESQUIERES, Pr herve.ghesquieres@chu-lyon.fr
Contact: Pierre SUJOBERT, Dr pierre.sujobert@chu-lyon.fr

Locations
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France
Service d'hématologie biologique - Centre Hospitalier Lyon Sud - HCL Recruiting
Pierre-Bénite, France, 69495
Contact: Pierre SUJOBERT, Dr       pierre.sujobert@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03859544    
Other Study ID Numbers: 69HCL17_0692
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases