Study of the Pronostic Impact of Immunohistochemical, His... | NCT05347511

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

NCT05347511

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Apr 26, 2022Actual

Enrollment

94Estimated

Phase

Not provided

Conditions

Rare Disease With Poor Outcome

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2022Estimated

Primary Completion Date

Sep 1, 2022Estimated

Completion Date

Sep 1, 2022Estimated

First Submitted Date

Apr 20, 2022

First Submission Date that Met QC Criteria

Apr 20, 2022

First Posted Date

Apr 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2022

Last Update Posted Date

Apr 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

94Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Systemic DLBCL

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Description

Formalin-fixed paraffin-embedded (FFPE) are available for 90 patients and will be used for NGS and Immunohistochemistry.