Feasibility of ORGAnoids in Routine Clinical Practice for Molecular Analysis of the GLIOvascular Niche in Patients With Primary Brain Tumors.
ORGA-GLIO
2 other identifiers
interventional
30
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2025
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2025
CompletedFirst Posted
Study publicly available on registry
June 19, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
June 19, 2025
June 1, 2025
2 years
June 11, 2025
June 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
7 days
Study Arms (1)
Ex-vivo Organoid culture
EXPERIMENTALex-vivo organoid culture after tumor resection
Interventions
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
Eligibility Criteria
You may qualify if:
- 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®).
You may not qualify if:
- 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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Groupe Hospitalier du Havre
Le Havre, France
Centre Henri Becquerel
Rouen, France
CHU Rouen
Rouen, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2025
First Posted
June 19, 2025
Study Start
July 1, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2029
Last Updated
June 19, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share