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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Ex-vivo organoid culture feasability [Срок оценки: 7 days]

Критерии участия

Критерии включения

• 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®).

Критерии исключения

• 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.).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 3 центра

• Groupe Hospitalier du Havre — Le Havre
• Centre Henri Becquerel — Rouen
• CHU Rouen — Rouen

Идентификаторы

NCT: NCT07029100 · CHB24.05 · 2024-A02153-44

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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