NCT04865315

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
31mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
May 2022Dec 2028

First Submitted

Initial submission to the registry

April 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

6.6 years

First QC Date

April 26, 2021

Last Update Submit

January 26, 2026

Conditions

Keywords

Prospective studyPatient-derived organoids

Outcome Measures

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.

    Baseline tumor resection and blood sampling

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Contra-inidication for neurosurgical resection of the tumor.
  • Incapacitated patient, unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht Radiation Oncology

Maastricht, Limburg, 6229ET, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue, blood

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Marc Vooijs, Prof. Dr.

    Maastro Radiaton Oncology clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2021

First Posted

April 29, 2021

Study Start

May 1, 2022

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations