- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04865315
A Living Tissue Bank of Patient-Derived Organoids From Glioma Tumors (HiLoGlio)
January 26, 2026 updated by: Maastricht Radiation Oncology
HiLoGlio Organoid Study: 'A Living Tissue Bank of Patient-Derived Organoids From Glioma Tumors'
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.
Study Overview
Status
Recruiting
Conditions
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:
- Establishment of primary patient-derived organoids (PDO) of 'de novo' and recurrent high-grade glioma (HGG) and low-grade glioma (LGG)
- 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)
- Investigation of combinations of new or standard glioma systemic treatments (i.e immunotherapy, chemotherapy) with or without radiation (i.e. protons, photons).
Secondary objectives
- Establishment of co-cultures of HGG and LGG organoids with immune cells.
- Investigation of radiation-triggered cell death mechanisms on PDOs after irradiation with photons and protons.
- Investigation of dedifferentiation mechanisms of LGG to HGG in the context of radiation w/wo immunotherapy.
Study Type
Observational
Enrollment (Estimated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Annika Noordink, Msc
- Phone Number: +31(0)884456010
- Email: annika.noordink@maastro.nl
Study Contact Backup
- Name: Chantal Overhof
- Phone Number: +31(0)884455686
- Email: chantal.overhof@maastro.nl
Study Locations
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Limburg
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Maastricht, Limburg, Netherlands, 6229ET
- Recruiting
- Maastricht Radiation Oncology
-
Contact:
- Marc Vooijs, Prof.Dr.
- Phone Number: +31(0)88 44 55 600
- Email: marc.vooijs@maastro.nl
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients who have an MRI lesion suspected for a low- or high grade glioma (newly diagnosed or recurrent), who are eligible for a resection of the tumor.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phenotypic, genetic, epigenetic proteomic and transcriptomic profile of the LGG/HGG PDOs
Time Frame: 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.
|
Baseline tumor resection and blood sampling
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marc Vooijs, Prof. Dr., Maastro Radiaton Oncology clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Study Registration Dates
First Submitted
April 26, 2021
First Submitted That Met QC Criteria
April 26, 2021
First Posted (Actual)
April 29, 2021
Study Record Updates
Last Update Posted (Actual)
January 27, 2026
Last Update Submitted That Met QC Criteria
January 26, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HiLoGlio Organoid Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All obtained research data points and information will be added in a coded manner to the existing database of Laboratory Radiotherapy, located on a MUMC+ hosted and secured server and is password protected.
A dedicated, trained person will add all genetic and research information from this project to the database, which was especially designed for this research.
Only coded information will be extracted and used for the downstream research analyses.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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