Characterisation of TIM-3/Gal-9 Immune Checkpoints in Pri... | NCT05133505

Studies
Characterisation of TIM-3/Gal-9 Immune Checkpoints in Primary Central Nervous System Diffuse Large B Cell Lymphomas

NCT05133505

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Nov 24, 2021Actual

Enrollment

65Actual

Phase

Not provided

Conditions

Lymphoma, B-Cell

Interventions

Not provided

Countries

France

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

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2002Actual

Primary Completion Date

Oct 1, 2021Actual

Completion Date

Nov 1, 2021Actual

First Submitted Date

Nov 12, 2021

First Submission Date that Met QC Criteria

Nov 12, 2021

First Posted Date

Nov 24, 2021Actual

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

Nov 12, 2021

Last Update Posted Date

Nov 24, 2021Actual

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 diffuse large B cell lymphoma is a rare and aggressive entity of diffuse large B cell lymphoma. A previous transcriptomic study showed an overexpression of TIM-3 and Gal-9 in the tumor microenvironment. The investigators aimed to characterise TIM-3/Gal-9 immune checkpoints by using immunohistochemistry in the tumor microenvironment of primary central nervous system diffuse large B cell lymphoma.

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

No data available

No data is available for this block.

Enrollment

65Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TIM-3 and Gal-9 immunohistochemical expression	TIM-3 and Gal-9 immunohistochemical expression by tumor and microenvironment cells	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

- patient with a Diagnosis of LBDGC-SNC

Exclusion criteria:

immunocompromised patients
patients with a history of previous or associated low-grade lymphoma
patients with a history of systemic LBDGC with secondary localization to the SNC

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patient of Primary central nervous system diffuse large B cell lymphoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
aline desrumaux, MD, PhD	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uh Montpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016393	Lymphoma, B-Cell

Ancestor Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided