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Trial record 77 of 1118 for:    Recruiting, Not yet recruiting, Active, not recruiting, Completed, Enrolling by invitation, Approved for marketing Studies | glioblastoma

In Situ Immune Parameters and Their Prognostic Role on the Survival of Patients With Glioblastoma (IMMUNOGLIO)

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ClinicalTrials.gov Identifier: NCT03481231
Recruitment Status : Not yet recruiting
First Posted : March 29, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

Brief Summary:

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

Detailed Description:

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


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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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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
24 ml blood sample + tumor samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patient with a glioblastoma
Criteria

Inclusion Criteria:

  1. Patients with newly diagnosed, brain tumor
  2. Gross or near total resection of the contrast-enhancing tumor mass decides by the neurosurgeron.
  3. Subjects ≥18 and ≤75 years of age at surgery
  4. Patients must be able to understand and sign the informed consent documents indicating that they are aware of the investigational nature of this study.
  5. Confirmation of the diagnosis of grade IV GBM by the local pathologist with an independent neuropathologist who will review this diagnosis
  6. 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.
  7. Tumor biopsy for biological analysis has to be performed before using ultrasonic surgery

Exclusion Criteria:

  1. Patient with other type of primary brain tumor or metastases
  2. Patients with only biopsy performed for the diagnosis
  3. Subjects under guardianship, curatorship or judicial protection
  4. Female subjects who are pregnant or breast-feeding

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): NCT03481231


Contacts
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Contact: François GHIRINGHELLI, PU-PU 03.80.73.34.02 FGhiringhelli@cgfl.fr
Contact: Emilie REDERSTORFF 03.45.34.81.16 erederstorff@cgfl.fr

Sponsors and Collaborators
Centre Georges Francois Leclerc

Additional Information:

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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