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

High Grade Glioma Clinical Trial

— HiLoGlio  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04865315
• Other study ID #: HiLoGlio Organoid Study
• Status: Active, not recruiting
• Start date: May 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioma
• High Grade Glioma
• Low-grade Glioma

Locations

Country	Name	City	State
Netherlands	Maastricht Radiation Oncology	Maastricht	Limburg

Sponsors (4)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	Maastricht University Medical Center, Ziekenhuis Oost-Limburg, Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phenotypic, genetic, epigenetic proteomic and transcriptomic profile of the LGG/HGG PDOs	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.	Baseline tumor resection and blood sampling