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HiLoGlio: A Living Tissue Bank of Patient-Derived Organoids From Glioma Tumors

Sponsor
Maastricht Radiation Oncology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04865315
Collaborator
Maastricht University Medical Center (Other), Zuyderland Medisch Centrum (Other), Ziekenhuis Oost-Limburg (Other)
50
Enrollment
1
Location
31
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is a high medical need to improve treatment outcome for high-grade and low-grade glioma since no curative treatment is available. To achieve this goal, a broader understanding is needed of the causes of inter-and intratumoral heterogeneity; glioma dedifferentiation and invasion; the major determinants of malignancy and treatment failure in glioma patients. Patient-derived organoid (PDOs) of high-grade gliomas and low-grade gliomas will be used to identify the mechanisms that underlie this malignant behaviour and treatment resistance. This insight may be used to develop patient avatars to simultaneously test multiple new treatment modalities that are predictive for survival and quality of life of glioma patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To establish primary patient-derived three-dimensional organoid cultures from low grade and high-grade gliomas to study the mechanisms that contribute to i.e.

    resistance to radiotherapy and/or chemotherapy and immunotherapy, dedifferentiation, tumor invasion among others, in primary and recurrent tumors.

    Primary Objectives:

    1. Establishment of primary patient-derived organoids (PDO) of 'de novo' and recurrent high-grade glioma (HGG) and low-grade glioma (LGG)

    2. Phenotypic, genetic, epigenetic and transcriptomic characterization of HGG and LGG organoids and resemblance to the parental tumor (i.e. characterization of specific cell populations and genomic and transcriptomic profiles of PDOs)

    3. Investigation of combinations of new or standard glioma systemic treatments (i.e immunotherapy, chemotherapy) with or without radiation (i.e. protons, photons).

    Secondary objectives

    1. Establishment of co-cultures of HGG and LGG organoids with immune cells.

    2. Investigation of radiation-triggered cell death mechanisms on PDOs after irradiation with photons and protons.

    3. Investigation of dedifferentiation mechanisms of LGG to HGG in the context of radiation w/wo immunotherapy.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    HiLoGlio Organoid Study: 'A Living Tissue Bank of Patient-Derived Organoids From Glioma Tumors'
    Actual Study Start Date :
    May 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Low grade glioma patients

    Patients who have a MRI lesion suspected for a low grade glioma (newly diagnosed or recurrent), who are eligible for a resection of the tumor
    High grade glioma patients

    Patients who have a MRI lesion suspected for a high grade glioma (newly diagnosed or recurrent), who are eligible for a resection of the tumor

    Outcome Measures

    Primary Outcome Measures

    1. Phenotypic, genetic, epigenetic proteomic and transcriptomic profile of the LGG/HGG PDOs [Baseline tumor resection and blood sampling]

      Phenotypic, genetic, epigenetic proteomic and transcriptomic profile of the LGG/HGG PDOs will be performed after establishing PDO and the data will be compared with the phenotypic, genetic, epigenetic, proteomic and transcriptomic profile of the parental tumor. DNA isolated from peripheral blood will be used as normal reference DNA for (epi)genetic profiling.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • MRI diagnosis of low grade glioma (LGG) or high grade glioma (HGG)

    • Age 18 years or older

    • Patient is eligible for a resection of the tumor

    Exclusion Criteria:

    • Contra-inidication for neurosurgical resection of the tumor.

    • Incapacitated patient, unable to give informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maastricht Radiation Oncology Maastricht Limburg Netherlands 6229ET

    Sponsors and Collaborators

    • Maastricht Radiation Oncology
    • Maastricht University Medical Center
    • Zuyderland Medisch Centrum
    • Ziekenhuis Oost-Limburg

    Investigators

    • Principal Investigator: Marc Vooijs, Prof. Dr., Maastro Radiaton Oncology clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maastricht Radiation Oncology
    ClinicalTrials.gov Identifier:
    NCT04865315
    Other Study ID Numbers:
    • HiLoGlio Organoid Study
    First Posted:
    Apr 29, 2021
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Maastricht Radiation Oncology
    Prospective study
    Patient-derived organoids
    Additional relevant MeSH terms:
    Glioma

    Study Results

    No Results Posted as of Aug 24, 2022