Feasibility of ORGAnoids in Routine Clinical Practice for Molecular Analysis of the GLIOvascular Niche in Patients With Primary Brain Tumors.
NCT ID: NCT07029100
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-07-01
2029-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Ex-vivo Organoid culture
ex-vivo organoid culture after tumor resection
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.).
18 Years
ALL
No
Sponsors
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Centre Henri Becquerel
OTHER
Responsible Party
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Locations
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Groupe Hospitalier du Havre
Le Havre, , France
Centre Henri Becquerel
Rouen, , France
CHU Rouen
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-A02153-44
Identifier Type: OTHER
Identifier Source: secondary_id
CHB24.05
Identifier Type: -
Identifier Source: org_study_id
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