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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07029100
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centre Henri Becquerel
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Ex-vivo Organoid culture

ex-vivo organoid culture after tumor resection

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Groupe Hospitalier du Havre, Le Havre 3003796, France

Status

Address

Groupe Hospitalier du Havre

Le Havre 3003796, ,

Site Contact

Marine Lacaud

[email protected]

+332 32 73 32 32

Centre Henri Becquerel, Rouen 2982652, France

Status

Address

Centre Henri Becquerel

Rouen 2982652, ,

Site Contact

Maxime Fontanilles

[email protected]

+33276673091

CHU Rouen, Rouen 2982652, France

Status

Address

CHU Rouen

Rouen 2982652, ,

Site Contact

Olivier Langlois

[email protected]

+33232888042

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