- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06430424
Study of Metabolic, Transcriptomic and Proteomic Characteristics in Relapsed Glioblastoma (GBrecurr)
Study of Metabolic, Genomic and Proteomic Modifications in Relapsed Glioblastoma. Identification or Prognostic Markers in Patients Undergoing Surgery for Relapsed Glioblastoma.
Study Overview
Status
Intervention / Treatment
Detailed Description
Glioblastomas are the most frequent and aggressive malignant Central Nervous System (CNS) tumors in adults, with a median survival of only 14 months.
Current treatment is based on surgery followed by radiochemotherapy (STUPP protocol), unchanged since 2005. Clinical trials evaluating immune checkpoint inhibitors and targeted therapies have largely failed to demonstrate efficacy in these tumors. In order to better understand the oncogenesis of glioblastoma and identify potential new therapeutic targets, the study of the characteristics of relapsed tumors compared with the initial tumor seems relevant.
The aim of this retrospective study is to investigate the transcriptomic, proteomic and metabolic characteristics of relapsed glioblastomas reoperated at the University Hospital of Bordeaux, France, between 2005 and 2023, for which tumor material is available. These analyses will be correlated with relapse-free and overall survival of the patients.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mathieu LARROQUETTE
- Phone Number: +33 5 56 79 58 08
- Email: mathieu.larroquette@chu-bordeaux.fr
Study Contact Backup
- Name: Julien ENGELHARDT
- Email: julien.engelhardt@chu-bordeaux.fr
Study Locations
-
-
-
Bordeaux, France, 33000
- Recruiting
- CHU de Bordeaux - Hôpital Saint-André, Service d'Oncologie Médicale
-
Contact:
- Mathieu LARROQUETTE
- Email: mathieu.larroquette@chu-bordeaux.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age > 18 years
- surgery for both primary and recurrent glioblastoma between 2005 and 2023 at the CHU de Bordeaux
Exclusion Criteria:
- systemic therapy received for non-glioblastoma tumor
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients operated for primary and recurrent glioblastoma
Patients operated for both primary and recurrent glioblastoma between 2005 and 2023 at the CHU de Bordeaux
|
Paired tumor samples diagnosis/relapse
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of metabolic changes involved in glioblastoma relapse
Time Frame: Up to 2 years after the start of the study
|
Relative abondance of metabolite and differential enzyme expression in a recurrence versus primary sample
|
Up to 2 years after the start of the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free survival
Time Frame: From date of the second surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
|
Progression-free survival of patients who underwent surgery for relapse glioblastoma after the surgery of relapse measured at time of inclusion
|
From date of the second surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
|
|
Overall survival
Time Frame: From date of the second surgery until the date of death from any cause, assessed up to 5 years
|
Overall survival of patients who underwent surgery for relapse glioblastoma after the surgery of relapse
|
From date of the second surgery until the date of death from any cause, assessed up to 5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2023/79
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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