Relapsed CancerGBrecurrNCT06430424
Study of Metabolic, Transcriptomic and Proteomic Characteristics in Relapsed Glioblastoma
An observational study of Relapsed Cancer and Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, run by University Hospital, Bordeaux at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Cancer, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
- What is being tested?
- Relapsed glioblastoma
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2024to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with relapsed glioblastomas reoperated at the University Hospital of Bordeaux, France, between 2005 and 2023, for which tumor material is available
Who may be able to join
- age > 18 years
- surgery for both primary and recurrent glioblastoma between 2005 and 2023 at the CHU de Bordeaux
Who cannot join
- systemic therapy received for non-glioblastoma tumor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Julien ENGELHARDT contact
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux - Hôpital Saint-André, Service d'Oncologie Médicale
Bordeaux, 33000
Mathieu LARROQUETTE, mathieu.larroquette@chu-bordeaux.fr
About this study
Official title: Study of Metabolic, Genomic and Proteomic Modifications in Relapsed Glioblastoma. Identification or Prognostic Markers in Patients Undergoing Surgery for Relapsed Glioblastoma.
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.
Read the 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.
- Being tested
- Relapsed glioblastoma
- Keywords
- Recurrent glioblastoma, Prognostic, Metabolism, Proteomic, Transcriptomic, Microbiota
- Medical subject headings
- Recurrence, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relapsed glioblastomaBiological
Paired tumor samples diagnosis/relapse
| Study group | Role | What they receive |
|---|---|---|
| Patients operated for primary and recurrent glioblastoma | Patients operated for both primary and recurrent glioblastoma between 2005 and 2023 at the CHU de Bordeaux Receives: Biological: Relapsed glioblastoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of metabolic changes involved in glioblastoma relapse
Relative abondance of metabolite and differential enzyme expression in a recurrence versus primary sample
Measured: Up to 2 years after the start of the study
Secondary outcomes (2)
Progression-free survival
Progression-free survival of patients who underwent surgery for relapse glioblastoma after the surgery of relapse measured at time of inclusion
Measured: 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
Overall survival of patients who underwent surgery for relapse glioblastoma after the surgery of relapse
Measured: From date of the second surgery until the date of death from any cause, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start5 Apr 2024
- Primary completionJul 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430424
- Sponsor's protocol ID
- CHUBX 2023/79
- Acronym
- GBrecurr
- Status last verified
- Jul 2025
- First submitted
- 27 Mar 2024
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Metabolic, Genomic and Proteomic Modifications in Relapsed Glioblastoma. Identification or Prognostic Markers in Patients Undergoing Surgery for Relapsed Glioblastoma.
- ClinicalTrials.gov ID
- NCT06430424
- Acronym / sponsor ID
- GBrecurr / CHUBX 2023/79
- Keywords
- Recurrent glioblastoma, Prognostic, Metabolism, Proteomic, Transcriptomic, Microbiota
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients operated for primary and recurrent glioblastoma | – | Biological: Relapsed glioblastomaPatients operated for both primary and recurrent glioblastoma between 2005 and 2023 at the CHU de Bordeaux |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with relapsed glioblastomas reoperated at the University Hospital of Bordeaux, France, between 2005 and 2023, for which tumor material is available
Key inclusion criteria (2 listed)
- age > 18 years
- surgery for both primary and recurrent glioblastoma between 2005 and 2023 at the CHU de Bordeaux
Key exclusion criteria (1 listed)
- systemic therapy received for non-glioblastoma tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relapsed glioblastomaPaired tumor samples diagnosis/relapse | Biological | Patients operated for primary and recurrent glioblastoma |
Primary outcome
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
2 secondary outcomes
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
Overall survival
Time frame: From date of the second surgery until the date of death from any cause, assessed up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julien ENGELHARDT contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed Cancer and Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathieu LARROQUETTE (+33 5 56 79 58 08, mathieu.larroquette@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of metabolic changes involved in glioblastoma relapse (time frame: Up to 2 years after the start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.