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Recruiting NCT04865315

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

Observational Low-grade Glioma High Grade Glioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Low-grade Glioma, High Grade Glioma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Primary outcome measures

  • Phenotypic, genetic, epigenetic proteomic and transcriptomic profile of the LGG/HGG PDOs [Time frame: Baseline tumor resection and blood sampling]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Netherlands · 1 center
  • Maastricht Radiation Oncology — Maastricht

Identifiers

NCT: NCT04865315 · HiLoGlio Organoid Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗