## Protocol Section
### Identification Module
**NCT ID:** NCT06430424

**Acronym:** GBrecurr

**Brief Title:** 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.

#### Organization Study ID Info
**ID:** CHUBX 2023/79
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Bordeaux
### Status Module
#### Completion Date
**Date:** 2026-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-27
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Bordeaux

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Relapsed Cancer

- Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype

**Keywords:**

- Recurrent glioblastoma

- Prognostic

- Metabolism

- Proteomic

- Transcriptomic

- Microbiota

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients operated for both primary and recurrent glioblastoma between 2005 and 2023 at the CHU de Bordeaux

**Intervention Names:**

- Biological: Relapsed glioblastoma

**Label:** Patients operated for primary and recurrent glioblastoma

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients operated for primary and recurrent glioblastoma

**Description:** Paired tumor samples diagnosis/relapse

**Name:** Relapsed glioblastoma

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** Relative abondance of metabolite and differential enzyme expression in a recurrence versus primary sample

**Measure:** Evaluation of metabolic changes involved in glioblastoma relapse

**Time Frame:** Up to 2 years after the start of the study

#### Secondary Outcomes

**Description:** Progression-free survival of patients who underwent surgery for relapse glioblastoma after the surgery of relapse measured at time of inclusion

**Measure:** 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

**Description:** Overall survival of patients who underwent surgery for relapse glioblastoma after the surgery of relapse

**Measure:** Overall survival

**Time Frame:** From date of the second surgery until the date of death from any cause, assessed up to 5 years

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mathieu.larroquette@chu-bordeaux.fr

**Name:** Mathieu LARROQUETTE

**Phone:** +33 5 56 79 58 08

**Role:** CONTACT

**Contact 2:**

**Email:** julien.engelhardt@chu-bordeaux.fr

**Name:** Julien ENGELHARDT

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bordeaux

**Contacts:**

***Contact 1:***

- **Email:** mathieu.larroquette@chu-bordeaux.fr

- **Name:** Mathieu LARROQUETTE

- **Role:** CONTACT

**Country:** France

**Facility:** CHU de Bordeaux - Hôpital Saint-André, Service d'Oncologie Médicale

**Zip:** 33000

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001254

- Term: Astrocytoma

- ID: D000005910

- Term: Glioma

- ID: D000018302

- Term: Neoplasms, Neuroepithelial

- ID: D000017599

- Term: Neuroectodermal Tumors

- ID: D000009373

- Term: Neoplasms, Germ Cell and Embryonal

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009380

- Term: Neoplasms, Nerve Tissue

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M9019

- Name: Glioblastoma

- Relevance: HIGH

- As Found: Glioblastoma

- ID: M4561

- Name: Astrocytoma

- Relevance: LOW

- As Found: Unknown

- ID: M9020

- Name: Glioma

- Relevance: LOW

- As Found: Unknown

- ID: M20446

- Name: Neoplasms, Neuroepithelial

- Relevance: LOW

- As Found: Unknown

- ID: M19845

- Name: Neuroectodermal Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M20388

- Name: Neuroectodermal Tumors, Primitive

- Relevance: LOW

- As Found: Unknown

- ID: M12318

- Name: Neoplasms, Germ Cell and Embryonal

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12325

- Name: Neoplasms, Nerve Tissue

- Relevance: LOW

- As Found: Unknown

- ID: T2518

- Name: Glioblastoma

- Relevance: HIGH

- As Found: Glioblastoma

- ID: T2519

- Name: Glioma

- Relevance: LOW

- As Found: Unknown

- ID: T4092

- Name: Neuroepithelioma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005909

- Term: Glioblastoma

### Misc Info Module

- Version Holder: 2024-05-31
