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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Groupe Hospitalier du Havre
Le Havre, France
Centre Henri Becquerel
Rouen, France
CHU Rouen
Rouen, France
Start Date
July 1, 2025
Primary Completion Date
July 1, 2027
Completion Date
July 1, 2029
Last Updated
June 19, 2025
30
ESTIMATED participants
Ex-vivo organoid culture
OTHER
Lead Sponsor
Centre Henri Becquerel
NCT05839379
NCT06860594
Data Source & Attribution
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