About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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®).
Disqualifiers
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.).
Trial design
Single group
Treatments tested in this trial
Ex-vivo organoid culture
Other interventionex-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
Treatment groups
Trial outcomes
Primary outcomes
Ex-vivo organoid culture feasability
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
Sponsors and contacts
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