Study of the Pronostic Impact of Immunohistochemical, Histological and Radiological Factors in Patients With Primary Central Nervous System Lymphoma.

Study of the Pronostic Impact of Immunohistochemical, Histological, Radiological and Molecular Factors in Patients With Primary Central Nervous System Lymphoma

Primary Central Nervous System Lymphoma (PCNSL) have a specific mutational profile in comparison to systemic diffuse large cells lymphoma (DLBCLs) that can be related to the expression of immunohistochemical markers as cyclon, NPM1, CD30, and P53 which could be predictive factor for prognosis and/or chemotherapy response. The main objective of this study is to identify new prognostic factors and new potential therapeutic targets.

The secondary objectives are to correlate the histological, the radiological and the clinical's informations of these patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Rare Disease With Poor Outcome

• Study Type: Observational
• Enrollment (Anticipated): 94

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults' immunocompetent patients treated at the University Hospital of Nancy are included if they had a DLBCL's PCNSL diagnosed between January 2011 and December 2019, without regard to the clinical outcome.. All the patients are included in the LOC network database (Lymphomes oculo-cerebraux) and had given their written consent for the use of their samples for studies. Biological and clinical data will be collected for each patient from original medical charts.

Description

Inclusion Criteria:

• PCNSL diagnosed between January 2011 and December 2019, without regard to the clinical outcome.
• Age > 18

Exclusion Criteria:

• Systemic DLBCL

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between the survival and the expression of Cyclon, NPM1 and CD30.	kaplan meyer	17/10/2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the correlation between the molecular abnormalities and the expression of Cyclon, NPM1 and CD30	mutational signature	17/10/2022

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Anticipated): April 20, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Rare Diseases
• Other Study ID Numbers: 2022PI003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No