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

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03859544
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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Hybridization-array analysis of this cohort has already revealed abnormalities associated with a poor prognosis (unpublished data).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	Phase
Central Nervous System Lymphoma	Other: Retrospective study

Study Design

• Study Type: Observational
• Anticipated 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: Jan 1, 2016
• Anticipated Primary Completion Date: Jan 1, 2020
• Anticipated Study Completion Date: Jan 1, 2020

Outcome Measures

Primary Outcome Measures

1. Progression free survival [Up to 48 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Service d'hématologie biologique - Centre Hospitalier Lyon Sud - HCL	Pierre-Bénite		France	69495

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT03859544
• Other Study ID Numbers: 69HCL17_0692
• First Posted: Mar 1, 2019
• Last Update Posted: Mar 1, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma

Study Results

No Results Posted as of Mar 1, 2019