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Patient-derived Glioma Stem Cell Organoids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04868396
Recruitment Status : Active, not recruiting
First Posted : April 30, 2021
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Brief Summary:

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.


Condition or disease Intervention/treatment
Glioblastoma Procedure: Tumor biopsy

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Glioma Stem Cell Organoids: Preclinical Model of Glioblastoma Heterogeneity to Explore Resistance Mechanisms to Conventional Treatment Schedules.
Actual Study Start Date : April 10, 2021
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
Glioblastoma patients
Glioblastoma patients selected to undergo surgical removal of a glioblastoma (based on MRI image).
Procedure: Tumor biopsy
Tumor material will be derived from 'left-over' tumor tissue that is not needed for standardised diagnostics (immune histochemistry and molecular testing).




Primary Outcome Measures :
  1. Organoid cultures [ Time Frame: Baselline ]
    Primary derived organoid cultures from GM

  2. Long term culturing and biobanking conditions for GM organoids [ Time Frame: Baseline ]
    Determine the frequency of primary, secondary and tertiary organoid formation, size distribution of the organoids, the rate of proliferation and cell death will be calculated.

  3. Intra-organoid heterogeneity reflects intra-tumoral genetic and epigenetic heterogeneity [ Time Frame: Baseline ]
    To assess whether intra-organoid heterogeneity reflects intra-tumoral genetic and epigenetic heterogeneity; with initial focus on MGMT promoter methylation status

  4. GM organoid model [ Time Frame: Baseline ]
    GM organoid model that reflects primary and secondary temozolomide resistance


Secondary Outcome Measures :
  1. Define oncogenic drivers [ Time Frame: Baseline ]
    Define oncogenic drivers in TMZ resistant GM cells.

  2. Organoid platform [ Time Frame: Baseline ]
    Set up organoid platform (MGMT methylated vs non-methylated) for drug screening.

  3. ctDNA [ Time Frame: Baseline ]
    Analyse ctDNA, secreted by organoids in medium/supernatans and corresponding patient derived plasma.


Biospecimen Retention:   Samples With DNA
Tumor biopsies taken during surgery Blood sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All these patients regardless of sex and ethnicity will be asked to co-operate in this study.

The patients will be consecutively included.

Criteria

Inclusion Criteria:

  • MRI imaging suggestive for glioblastoma
  • > 18 years of age

Exclusion Criteria:

  • Karnofsky index < 70
  • Clotting disorders
  • Neurosurgical contraindications for gross total resection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04868396


Locations
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Netherlands
Maastricht UMC+
Maastricht, Limburg, Netherlands, 6202AZ
Maastricht Radiation Oncology
Maastricht, Limburg, Netherlands, 6229ET
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
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Principal Investigator: Marc Vooijs, Prof. Dr. Maastro Radiaton Oncology
Principal Investigator: A. Hoeben, Dr. Maastricht UMC+
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Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT04868396    
Other Study ID Numbers: Glioma stem cell organoids
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht Radiation Oncology:
Stem cells
Organoids
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue