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NCT Number: NCT07029100

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier du Havre, Le Havre, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Ex-vivo organoid culture

Other

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 outcomes

  1. Ex-vivo organoid culture feasability

    Time frame: 7 days

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Doriane Richard, PhD

CONTACT

[email protected]

+33232082985

Maxime Fontanille, MD,PhD

CONTACT

[email protected]

+33276673091

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Acronym: ORGA-GLIO

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Jun 19, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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