Study of Metabolic, Transcriptomic and Proteomic Characteristics in Relapsed Glioblastoma

Relapsed Cancer Clinical Trial

— GBrecurr  

Official title:

Study of Metabolic, Genomic and Proteomic Modifications in Relapsed Glioblastoma. Identification or Prognostic Markers in Patients Undergoing Surgery for Relapsed Glioblastoma.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06430424
• Other study ID #: CHUBX 2023/79
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
• Relapsed Cancer

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