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

Study Purpose

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.

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.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

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.	NCT04865315
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.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Maastricht Radiation Oncology
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Marc Vooijs, Prof. Dr.
Principal Investigator Affiliation	Maastro Radiaton Oncology clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Low-grade Glioma, High Grade Glioma

Additional Details

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.

Arms & Interventions

Arms

: 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

Interventions

Contact a Trial Team

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International Sites

Maastricht Radiation Oncology, Maastricht, Limburg, Netherlands

Status

Recruiting

Address

Maastricht Radiation Oncology

Maastricht, Limburg, 6229ET

Site Contact

Marc Vooijs, Prof.Dr.

[email protected]

+31(0)88 44 55 600

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