Feasibility of ORGAnoids in Routine Clinical Practice for Molecular Analysis of the GLIOvascular Niche in Patients With Primary Brain Tumors.

NCT07029100 · tracked via the Priya Life Science France tracker

Sponsor

Centre Henri Becquerel

Phase

Not applicable

Started

2025-07-01

Last updated

2025-06-19

Condition(s) studied

Glioblastoma

Investigational drug(s) / intervention(s)

Ex-vivo organoid culture

Ex-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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.).

Primary outcome measure(s)

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

Trial sites (3)

Facility	City	Region
Groupe Hospitalier du Havre	Le Havre	France
Centre Henri Becquerel	Rouen	France
CHU Rouen	Rouen	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07029100 on ClinicalTrials.gov ↗ ← All trials in France