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

ConditionGlioblastoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Henri Becquerel

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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®).

Disqualifiers

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.).

Trial design

Design model

Single group

Treatments tested in this trial

  • Ex-vivo organoid culture

    Other intervention

    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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Ex-vivo Organoid cultureExperimental treatment 1 intervention

Trial outcomes

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

Time frame
7 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: