Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04868396 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Patient-derived Glioma Stem Cell Organoids

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 20, 2024 (before its estimated September 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary and study completion dates: Sep 1, 2024 to Sep 1, 2025v4
  2. Notable Primary completion date: Sep 1, 2022 to Sep 1, 2024 Completion date: Jan 1, 2023 to Sep 1, 2024v3 Show 1 more changeShow less
    • Completion date: Jan 1, 2023 to Sep 1, 2024
  3. Notable Primary completion date: Sep 1, 2021 to Sep 1, 2022 Completion date: Jan 1, 2022 to Jan 1, 2023v2 Show 1 more changeShow less
    • Completion date: Jan 1, 2022 to Jan 1, 2023
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Rationale: Glioblastoma (GM) is the most frequent incurable adult brain tumor with median survival of 15 months after diagnosis, despite extensive treatment with surgery, radiation therapy and chemotherapy. Tumor recurrence is inevitable after which life prolonging therapies are no longer available. The development of new treatments for GM is being hampered by inter-and intratumoral heterogeneity of tumors and their microenvironment, which currently cannot be predicted accurately with current diagnostics. Objective: To establish primary patient derived organoid cultures from GM to study mechanisms that contribute to aggressive tumor growth and treatment resistance in primary and recurrent GM. Study design: Preclinical study, using patient derived glioblastoma tissue. Study population: Patients 18 years or older, with newly diagnosed glioblastoma. Main study parameters/endpoints: Intra-and inter organoid genetic and epigenetic heterogeneity that is representative for GM. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Minimal burden, since the biopsies are part of a regular neurosurgical procedure (debulking); which intends to eradicate the macroscopical tumorload in order to optimize survival benefit. The tissue (biopsy) that will be used for this trial is part of the tumor tissue that is resected during the standard debulking. Benefit: no benefit for the patient.
Trial Details
NCT Number NCT04868396
Lead Sponsor Maastricht Radiation Oncology
Conditions Glioblastoma
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov