NCT03687099

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2019

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

May 17, 2018

Last Update Submit

July 15, 2020

Conditions

Keywords

GlioblastomaCD45LymphocytesMicrogliaMacrophage

Outcome Measures

Primary Outcomes (1)

  • number of cells which express CD45 in the immunological environment from GBM.

    number of cells which express CD45 in the immunological environment from GBM, with using NanoString/RNAseq (NGS) and immunohistology

    1

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Histological samples of GBM

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2018

First Posted

September 27, 2018

Study Start

April 30, 2018

Primary Completion

November 8, 2019

Study Completion

November 8, 2019

Last Updated

July 16, 2020

Record last verified: 2020-07

Locations