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Not yet recruitingNCT07029100ORGA-GLIOUpdated Jun 19, 2025

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

An interventional study of Ex-vivo organoid culture in Glioblastoma, sponsored by Centre Henri Becquerel. Not yet recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-19.

Sponsored by Centre Henri Becquerel · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Glioblastoma

Keywords

  • glioblastoma
  • organoide
  • molecular analysis
03

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's planned enrollment of 30 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Centre Henri Becquerel is the lead sponsor of 57 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.).
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Ex-vivo Organoid culture

    ex-vivo organoid culture after tumor resection

    Other: Ex-vivo organoid culture

Interventions

  • OtherEx-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

06

What researchers measure

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

07

Study locations

3 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07029100
Lead sponsor
Centre Henri Becquerel
Responsible party
Sponsor
First posted
Jun 19, 2025
Start date
Jul 1, 2025 (estimated)
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2029 (estimated)
Last update
Jun 19, 2025

Study contacts

Maxime Fontanille, MD,PhD
Contact
maxime.fontanilles@chb.unicancer.fr
+33276673091
Doriane Richard, PhD
Contact
doriane.richard@chb.unicancer.fr
+33232082985

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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