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OpenTrials
Completed

NCT Number: NCT03687099

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens-Picardie

Amiens, 80054, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

Histological samples from 10 GBM removed from patients with long-term survival and 10 GBM removed from patients with short-term survival

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: GLIOBLASTOMES

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 27, 2018
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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