Immunological and Functional Characterization of Cellular Population CD45+ Infiltrating Human Glioblastoma (GLIOBLASTOMES)

July 15, 2020 updated by: Centre Hospitalier Universitaire, Amiens
Despite advances in neurosurgery , radiotherapy and chemotherapy, the median survival in GBM patients is only 15 months from diagnosis. Immunotherapy by checkpoint inhibitors (PD1 /PDL-1) appears as a promising treatment for many cancers. However, first clinical results are disappointing for GBM. An hypothesis is the immunosuppressive activity from infiltrating non-tumor cells. Conversion of non-tumor cells from an immunosuppressive to an immuno-activating phenotype could be attempted in a therapeutic perspective.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An important and constant infiltration of cells marked with CD45 has been observed in 77 GBM studied for the prognostic value of PDL1 and IL17 infiltration (in association with Pr Ghiringhelli ; INSERM ; Dijon) . However, CD45 is present at the surface of all leucocytes. The purpose of this project is to better characterize the nature and functionality of the CD45+ cells that infiltrate GBM (lymphocytes and their sub-types, macrophages, microglial cells). Formalin-fixed paraffin-embedded GBM samples will be studied. A panel of immune cell antibody will be used for the immuno-histological (IH) study. Furthermore, the investigator will compare these data with those obtained by the nanoString technology, a multiplexed measurement of gene expression.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens-Picardie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Histological samples of GBM

Description

Inclusion Criteria:

  • Formalin-fixed paraffin-embedded GBM samples from tumor bank of the pathological laboratory of the University Hospital of Amiens-Picardie.
  • Histologic diagnosis of a glioblastoma according to the WHO classification of central nervous system
  • Radical surgical removal in order to have enough histological material and to homogenize the main prognostic factor that is the surgical removal.
  • Patients with more than 18 years old.
  • Patients informed who have signed a consent form for using the tumor for research purposes without personal benefit. If patients were died, absence of objection known for the anonymous use of the tumor for scientific purpose.
  • Be insured under one social security system.
  • Committee for the protection of persons approval.

Exclusion Criteria:

  • Relapsed GBM
  • Other brain tumors.
  • Medical, psychological or social conditions not allowing the comprehension of the conduct of the study for patients able to give their opinion.
  • Patient under curatorship.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of cells which express CD45 in the immunological environment from GBM.
Time Frame: 1
number of cells which express CD45 in the immunological environment from GBM, with using NanoString/RNAseq (NGS) and immunohistology
1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2018

Primary Completion (Actual)

November 8, 2019

Study Completion (Actual)

November 8, 2019

Study Registration Dates

First Submitted

May 17, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2018_843_0011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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