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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06430424
Other study ID # CHUBX 2023/79
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date April 2026

Study information

Verified date April 2024
Source University Hospital, Bordeaux
Contact Mathieu LARROQUETTE
Phone +33 5 56 79 58 08
Email mathieu.larroquette@chu-bordeaux.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Glioblastomas are the most frequent and aggressive malignant tumors of the CNS in adults, with almost systematic relapse despite treatment with surgery followed by radio-chemotherapy (STUPP protocol). The aim of this study is to better characterize transcriptomic, proteomic and metabolic changes in relapsed glioblastoma compared to the initial tumor, in order to identify new prognostic markers and potential new therapeutic targets.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date April 2026
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
Relapsed glioblastoma
Paired tumor samples diagnosis/relapse

Locations

Country Name City State
France CHU de Bordeaux - Hôpital Saint-André, Service d'Oncologie Médicale Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of metabolic changes involved in glioblastoma relapse 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 Progression-free survival 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
Secondary Overall survival 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
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