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

NCT03859544 | Unknown

• 1 other identifier: 69HCL17_0692
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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Hybridization-array analysis of this cohort has already revealed abnormalities associated with a poor prognosis (unpublished data).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.

Conditions

Central Nervous System Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Analysis of progression-free survival correlated with genomic data and mutation data

  Up to 48 months

Interventions

Retrospective study OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study focuses on adult subjects (male and female) with central nervous system lymphoma.

You may qualify if:

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

You may not qualify if:

• \<18 old years
• Other diagnosis than lymphoma of the central nervous system
• No consent form signed

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service d'hématologie biologique - Centre Hospitalier Lyon Sud - HCL

Pierre-Bénite, 69495, France

RECRUITING

MeSH Terms

Interventions

Retrospective Studies

Intervention Hierarchy (Ancestors)

Case-Control Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Cohort Studies; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Hervé GHESQUIERES, Pr

CONTACT

herve.ghesquieres@chu-lyon.fr

Pierre SUJOBERT, Dr

CONTACT

pierre.sujobert@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 1, 2019
• Study Start: January 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 1, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)