GlioblastomaGLIOBLASTOMESNCT03687099
Immunological and Functional Characterization of Cellular Population CD45+ Infiltrating Human Glioblastoma
An observational study of Glioblastoma, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2018to 8 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Histological samples of GBM
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Glioblastoma
- Being tested
- no intervention
- Keywords
- Glioblastoma, CD45, Lymphocytes, Microglia, Macrophage
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Histological samples from 10 GBM removed from patients with long-term survival and 10 GBM removed from patients with short-term survival
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start30 Apr 2018
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687099
- Sponsor's protocol ID
- PI2018_843_0011
- Acronym
- GLIOBLASTOMES
- Status last verified
- Jul 2020
- First submitted
- 17 May 2018
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological and Functional Characterization of Cellular Population CD45+ Infiltrating Human Glioblastoma
- ClinicalTrials.gov ID
- NCT03687099
- Acronym / sponsor ID
- GLIOBLASTOMES / PI2018_843_0011
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, CD45, Lymphocytes, Microglia, Macrophage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Histological samples of GBM
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionHistological samples from 10 GBM removed from patients with long-term survival and 10 GBM removed from patients with short-term survival | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of cells which express CD45 in the immunological environment from GBM. (time frame: 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.