ClinicalTrials.gg
RecruitingNCT04865315HiLoGlioUpdated Jan 27, 2026

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

An observational study in Low-grade Glioma and High Grade Glioma, sponsored by Maastricht Radiation Oncology. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by Maastricht Radiation Oncology · Observational

From the registry’s dates

  • Started May 2022; still recruiting 4 years 6 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

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:

  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.
02

Conditions studied

  • Low-grade Glioma
  • High Grade Glioma

Browse trials for

Keywords

  • Prospective study
  • Patient-derived organoids
03

In context

Glioma

1,452 studies on the registry are indexed under Glioma; 349 are open to participants now.

This study's planned enrollment of 50 is below the median of 90 across 273 observational studies indexed under Glioma.

Browse Glioma studies →

Lead sponsor

Maastricht Radiation Oncology is the lead sponsor of 106 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Contra-inidication for neurosurgical resection of the tumor.
  • Incapacitated patient, unable to give .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline tumor resection and blood sampling

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2022 (actual). Primary completion is estimated for Dec 2028, 79 months after the start.

Of 113 non-industry observational studies under Glioma, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 104. This study's planned 79 months is above that.

Counting every sponsor, half of 123 studies reached it within 60 months; a quarter within 29 and three quarters within 104.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 26, 2021
First posted
Apr 29, 2021
StartActual
May 1, 2022
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2028
Last update
Jan 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04865315
Collaborators
Maastricht University Medical Center, Zuyderland Medisch Centrum, Ziekenhuis Oost-Limburg
Responsible party
Sponsor
First posted
Apr 29, 2021
Start date
May 1, 2022
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jan 27, 2026

Study contacts

Annika Noordink, Msc
Contact
annika.noordink@maastro.nl
+31(0)884456010
Chantal Overhof
Contact
chantal.overhof@maastro.nl
+31(0)884455686
Marc Vooijs, Prof. Dr.
principal investigator · Maastro Radiaton Oncology clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion