In Situ Immune Parameters and Their Prognostic Role on the Survival of Patients With Glioblastoma (IMMUNOGLIO)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03481231 |
|
Recruitment Status :
Not yet recruiting
First Posted : March 29, 2018
Last Update Posted : July 16, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Glioblastoma (GBM) is the most frequent brain tumor. Currently survival is poor and few treatments are available. Recent data show that there is no immune privilege of the central nervous system (CNS) and that GBM are invaded by effector CD8 T cells, letting us hypothesis that GBM growth is dependent of immunosurveillance.
The aim of this study is to better understand the antitumor immune response against GBM to unravel new effectors and immunosuppressive pathways important for the regulation of anticancer immunity and to discover new immune activating strategies with the objectives to isolate subgroups of GBMs that could benefit from an immunotherapy approach. To achieve this goal, GBM tumor samples and a blood sample will be collected during the initial tumor resection.
The sites involved in the recruitment of the patients will be the neurosurgical teams in Brussel, Dijon, Nantes and Padova.
| Condition or disease |
|---|
| Glioblastoma |
Primary objective :
The primary objective is to determine for each of the 3 molecular subtypes of glioblastoma the predictive performance on 1-year overall survival of in situ immune parameters
Secondary objectives :
To identify the best combination of in vivo immune parameters that is predictive of 1-year overall survival To determine the impact of immune parameters on overall survival
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 311 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 24 Years |
| Official Title: | In Situ Immune Parameters and Their Prognostic Role on the Survival of Patients With Glioblastoma |
| Estimated Study Start Date : | December 2018 |
| Estimated Primary Completion Date : | December 2018 |
| Estimated Study Completion Date : | December 2020 |
- overall survival [ Time Frame: 24 months ]Determination for each of the 3 molecular subtypes of glioblastoma the predictive performance on 1-year overall survival of in situ immune parameters
Biospecimen Retention: None Retained
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Patients with newly diagnosed, brain tumor
- Gross or near total resection of the contrast-enhancing tumor mass decides by the neurosurgeron.
- Subjects ≥18 and ≤75 years of age at surgery
- Patients must be able to understand and sign the informed consent documents indicating that they are aware of the investigational nature of this study.
- Confirmation of the diagnosis of grade IV GBM by the local pathologist with an independent neuropathologist who will review this diagnosis
- Primary therapy must consist of surgical resection with the intent for a gross or near total resection of the contrast-enhancing tumor mass, followed by conventional external beam radiation therapy and concurrent temozolomide chemotherapy.
- Tumor biopsy for biological analysis has to be performed before using ultrasonic surgery
Exclusion Criteria:
- Patient with other type of primary brain tumor or metastases
- Patients with only biopsy performed for the diagnosis
- Subjects under guardianship, curatorship or judicial protection
- Female subjects who are pregnant or breast-feeding
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): NCT03481231
| Contact: François GHIRINGHELLI, PU-PU | 03.80.73.34.02 | FGhiringhelli@cgfl.fr | |
| Contact: Emilie REDERSTORFF | 03.45.34.81.16 | erederstorff@cgfl.fr |
Additional Information:
| Responsible Party: | Centre Georges Francois Leclerc |
| ClinicalTrials.gov Identifier: | NCT03481231 History of Changes |
| Other Study ID Numbers: |
IMMUNOGLIO |
| First Posted: | March 29, 2018 Key Record Dates |
| Last Update Posted: | July 16, 2018 |
| Last Verified: | July 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |