- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05786144
Vestibular Schwannoma Organoids
January 28, 2026 updated by: Maastricht Radiation Oncology
Vestibular Schwannoma Stem Cell Organoids
In standard of care regularly planned surgery, tissue will be obtained from patients who are suspicious for having vestibular Schwannoma (on MRI).
The tissue that remains after the pathologist gathered sufficient for analysis, the remaining tissue is used for creating tumour stem cell organoids.
Study Overview
Status
Completed
Conditions
Detailed Description
This project constitutes scientific research since the presence of tumor stem cells has not been shown in schwannoma before.
Secondly the organoid model has not yet been described for VSs.
The correlation between effect in schwannoma organoids and in patients has to be evaluated but can proof to be very valuable since it has been shown in a number of tumors.
The tumor tissue will be acquired during regularly planned surgery.
The tissue that is used is what is left after sufficient material has been sent to the pathologist to make the diagnosis.
So the tissue that is used is removed routinely during surgery, but instead of banking it at the pathology department, it is used for the research project.
Blood samples that can be used to compare normal DNA to tumor cells DNA will be acquired from central lines that are routinely placed during these procedures, so no additional interventions will be done in acquiring the tissue and blood for this study.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Limburg
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Maastricht, Limburg, Netherlands, 6229HX
- Maastricht University Medical Center
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Maastricht, Limburg, Netherlands, 6229ET
- MAASTRO
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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 with a supsicion for vestibular schwannoma on an MRI for which surgery was indicated (approximately 10 per year in Maastricht).
Description
Inclusion Criteria:
- MRI with suspicion for vestibular schwannoma
- Indication for surgery in the skull base committee
- 18 years or older
Exclusion Criteria:
- Refusal to participate
- Younger than 18 years
- Incapacitated
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility
Time Frame: 10 years
|
Feasibility to create organoids from schwannoma tumour tissue and make a "living" biobank of these tissues in the laboratory to study the resistance mechanisms towards treatments.
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phenotype
Time Frame: 10 years
|
Comparing the phenotypical profile of the vestibular schwannoma organoid to the phenotypical profile of the original tumour.
|
10 years
|
|
Genetic
Time Frame: 10 years
|
Comparing the genetic profile of the vestibular schwannoma organoid to the genetic profile of the original tumour.
|
10 years
|
|
Epigenetic
Time Frame: 10 years
|
Comparing the epigenetic profile of the vestibular schwannoma organoid to the epigenetic profile of the original tumour.
|
10 years
|
|
Proteomic
Time Frame: 10 years
|
Comparing the proteomic profile of the vestibular schwannoma organoid to the proteomic profile of the original tumour.
|
10 years
|
|
Transcriptomic
Time Frame: 10 years
|
Comparing the transcriptomic profile of the vestibular schwannoma organoid to the transcriptomic profile of the original tumour.
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Koos Hovinga, Maastricht University Medical Center
- Principal Investigator: Marc Vooijs, MD, PhD, MAASTRO
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)
June 1, 2020
Primary Completion (Actual)
January 1, 2026
Study Completion (Actual)
January 1, 2026
Study Registration Dates
First Submitted
March 14, 2023
First Submitted That Met QC Criteria
March 14, 2023
First Posted (Actual)
March 27, 2023
Study Record Updates
Last Update Posted (Actual)
January 30, 2026
Last Update Submitted That Met QC Criteria
January 28, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Otorhinolaryngologic Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Nerve Sheath Neoplasms
- Peripheral Nervous System Neoplasms
- Neuroendocrine Tumors
- Ear Diseases
- Otorhinolaryngologic Neoplasms
- Cranial Nerve Diseases
- Neuroma
- Cranial Nerve Neoplasms
- Vestibulocochlear Nerve Diseases
- Retrocochlear Diseases
- Neurilemmoma
- Neuroma, Acoustic
Other Study ID Numbers
- Schwannoma organoids
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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