Glioblastoma
Conditions
Keywords
glioblastoma, organoide, molecular analysis
Brief summary
The main goal of ORGA-GLIO trial is to establish the feasibility in routine clinical practice of ex-vivo organoid cultures composed of tumor cells within their microenvironment (glioblastoma organoid - GBO) and intra- and peri-tumoral blood vessels (blood vessel organoid - BVO), derived from perioperative samples obtained during complete or partial surgical resection in patients with newly diagnosed glioblastoma.
Detailed description
The ORGA-GLIO study will be conducted in two stages: First stage: Establishment of the clinical-biological collection and addressing the primary objective. Step 1: Generation of tumor organoids (Glioblastoma Organoids - GBO), vascular organoids (Blood Vessel Organoids - BVO), and cell lines. Step 2: Phenotypic and molecular analyses of tumor and vascular organoids up to 7 days. Second stage: Utilization of the biological collection of organoids and blood samples. Utilization of the organoid collection and investigation of associations between the molecular and phenotypic and clinical and survival data collected during patient follow-up visits. Correlation of organoid evolution under experimental treatment procedure and evolution of plasma-based biomarker from corresponding patients and along first-line treatment schedule. All patients will be planned to receive standard of care for glioblastoma after resection, namely radiotherapy+temozolomide and TTFields.
Interventions
OTHEREx-vivo organoid culture
ex-vivo organoid cultures composed of tumor cells within their microenvironment (glioblastoma organoid - GBO) and intra- and peri-tumoral blood vessels (blood vessel organoid - BVO), derived from perioperative samples obtained during complete or partial surgical resection
Sponsors
Centre Henri Becquerel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient, male or female, adult (age ≥ 18 years), * Suspected of having a high-grade glioma based on preoperative multimodal MRI, * With an indication for tumor resection surgery, * And in a clinical condition suitable to undergo adjuvant treatment consisting of radiotherapy (normo- or hypo-fractionated) combined with temozolomide, with or without low-frequency electric fields (Tumor-Treating Fields®).
Exclusion criteria
* Current tumor pathology or history of tumor pathology in remission for less than 2 years * Pregnant or breastfeeding women, * Patients unable to understand the study for any reason or unable to comply with trial requirements (language barriers, psychological or geographical issues, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ex-vivo organoid culture feasability | 7 days | Proportion (in number of patients) of phenotypically and molecularly exploitable tumor and vascular organoid models (GBO+BVO) seven days after diagnostic neurosurgical removal (complete or partial excision) in patients with glioblastoma |
Countries
France
Contacts
Primary ContactMaxime Fontanille, MD,PhD
Backup ContactDoriane Richard, PhD
Outcome results
None listed