Feasibility of ORGAnoids in Routine Clinical Practice for Molecular Analysis of the GLIOvascular Niche in Patients With Primary Brain Tumors.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ex-vivo organoid culture.
- Who it may be relevant to
- Registry conditions: Glioblastoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other 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
Primary outcome measures
- Ex-vivo organoid culture feasability [Time frame: 7 days]
Eligibility criteria
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.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 3 centers
- Groupe Hospitalier du Havre — Le Havre
- Centre Henri Becquerel — Rouen
- CHU Rouen — Rouen
Identifiers
NCT: NCT07029100 · CHB24.05 · 2024-A02153-44