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

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ClinicalTrials.gov Identifier: NCT03687099
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:
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.

Condition or disease Intervention/treatment
Glioblastoma Other: no intervention

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Immunological and Functional Characterization of Cellular Population CD45+ Infiltrating Human Glioblastoma
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: no intervention
    Histological samples from 10 GBM removed from patients with long-term survival and 10 GBM removed from patients with short-term survival


Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Histological samples of GBM
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687099


Contacts
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Contact: BRUNO CHAUFFERT, Professor 03-22-45-54-99 chauffert.bruno@chu-amiens.fr

Locations
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France
CHU Amiens-Picardie Recruiting
Amiens, France, 80054
Contact: BRUNO CHAUFFERT, Professor    03-22-45-54-99    chauffert.bruno@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03687099    
Other Study ID Numbers: PI2018_843_0011
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Glioblastoma
CD45
Lymphocytes
Microglia
Macrophage
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue