Low-grade GliomaHiLoGlioNCT04865315
A Living Tissue Bank of Patient-Derived Organoids From Glioma Tumors
An observational study of Low-grade Glioma and High Grade Glioma, run by Maastricht Radiation Oncology at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low-grade Glioma, High Grade Glioma
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2022to Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Contra-inidication for neurosurgical resection of the tumor.
- Incapacitated patient, unable to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht Radiation Oncology
Maastricht, Limburg, 6229ET
Marc Vooijs, Prof.Dr., +31(0)88 44 55 600, marc.vooijs@maastro.nl
About this study
Official title: 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.
Read the 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.
- Conditions
- Low-grade Glioma, High Grade Glioma
- Keywords
- Prospective study, Patient-derived organoids
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline tumor resection and blood sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 May 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-grade GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center, Zuyderland Medisch Centrum, Ziekenhuis Oost-Limburg
- Responsible party
- Sponsor
- Investigators
- Marc Vooijs, Prof. Dr., Principal investigator, Maastro Radiaton Oncology clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865315
- Sponsor's protocol ID
- HiLoGlio Organoid Study
- Acronym
- HiLoGlio
- Status last verified
- Jan 2026
- First submitted
- 26 Apr 2021
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.