Vestibular SchwannomaNCT05786144
Vestibular Schwannoma Organoids
An observational study of Vestibular Schwannoma, run by Maastricht Radiation Oncology at 2 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Schwannoma
- How many people
- 100 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Jun 2020to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 with a supsicion for vestibular schwannoma on an MRI for which surgery was indicated (approximately 10 per year in Maastricht).
Who may be able to join
- MRI with suspicion for vestibular schwannoma
- Indication for surgery in the skull base committee
- 18 years or older
Who cannot join
- Refusal to participate
- Younger than 18 years
- Incapacitated
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Maastro
Maastricht, Limburg, 6229ET
Maastricht University Medical Center
Maastricht, Limburg, 6229HX
About this study
Official title: 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.
Read the 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.
- Conditions
- Vestibular Schwannoma
- Medical subject headings
- Neuroma, Acoustic
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
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.
Measured: 10 years
Secondary outcomes (5)
Phenotype
Comparing the phenotypical profile of the vestibular schwannoma organoid to the phenotypical profile of the original tumour.
Measured: 10 years
Genetic
Comparing the genetic profile of the vestibular schwannoma organoid to the genetic profile of the original tumour.
Measured: 10 years
Epigenetic
Comparing the epigenetic profile of the vestibular schwannoma organoid to the epigenetic profile of the original tumour.
Measured: 10 years
Proteomic
Comparing the proteomic profile of the vestibular schwannoma organoid to the proteomic profile of the original tumour.
Measured: 10 years
Transcriptomic
Comparing the transcriptomic profile of the vestibular schwannoma organoid to the transcriptomic profile of the original tumour.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Jun 2020
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular SchwannomaStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center
- Responsible party
- Sponsor
- Investigators
- Koos Hovinga, Principal investigator, Maastricht University Medical CenterMarc Vooijs, MD, PhD, Principal investigator, Maastro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786144
- Sponsor's protocol ID
- Schwannoma organoids
- Status last verified
- Jan 2026
- First submitted
- 14 Mar 2023
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Schwannoma Stem Cell Organoids
- ClinicalTrials.gov ID
- NCT05786144
- Acronym / sponsor ID
- Schwannoma organoids
- Conditions
- Vestibular Schwannoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a supsicion for vestibular schwannoma on an MRI for which surgery was indicated (approximately 10 per year in Maastricht).
Key inclusion criteria (3 listed)
- MRI with suspicion for vestibular schwannoma
- Indication for surgery in the skull base committee
- 18 years or older
Key exclusion criteria (3 listed)
- Refusal to participate
- Younger than 18 years
- Incapacitated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Phenotype
Time frame: 10 years
Genetic
Time frame: 10 years
Epigenetic
Time frame: 10 years
Proteomic
Time frame: 10 years
Transcriptomic
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koos Hovinga principal investigator
Maastricht University Medical Center
Marc Vooijs, MD, PhD principal investigator
Maastro
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Schwannoma, run by Maastricht Radiation Oncology at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.