Clinical trial NCT06430424: Study of Metabolic, Transcriptomic and Proteomic Characteristics in Relapsed Glioblastoma
Official title: Study of Metabolic, Genomic and Proteomic Modifications in Relapsed Glioblastoma. Identification or Prognostic Markers in Patients Undergoing Surgery for Relapsed Glioblastoma.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Relapsed Cancer
Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
Keywords: Recurrent glioblastoma
Prognostic
Metabolism
Proteomic
Transcriptomic
Microbiota
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsed glioblastomas reoperated at the University Hospital of Bordeaux, France, between 2005 and 2023, for which tumor material is available

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of metabolic changes involved in glioblastoma relapse
timeFrame: Up to 2 years after the start of the study
Secondary outcomes:
measure: Progression-free survival
timeFrame: 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
measure: Overall survival
timeFrame: From date of the second surgery until the date of death from any cause, assessed up to 5 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Saint-André, Service d'Oncologie Médicale
Study officials:
References: