Vestibular Schwannoma Organoids

Recruiting

• Conditions: Vestibular Schwannoma

• Registration Number: NCT05786144
• Lead Sponsor: Maastricht Radiation Oncology

Brief 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.

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 Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-03-14
• Study First Posted: 2023-03-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2030-06-01
• Study Completion: 2030-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility	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.

Secondary Outcome Measures

Name	Time	Method
Phenotype	10 years	Comparing the phenotypical profile of the vestibular schwannoma organoid to the phenotypical profile of the original tumour.
Epigenetic	10 years	Comparing the epigenetic profile of the vestibular schwannoma organoid to the epigenetic profile of the original tumour.
Genetic	10 years	Comparing the genetic profile of the vestibular schwannoma organoid to the genetic profile of the original tumour.
Proteomic	10 years	Comparing the proteomic profile of the vestibular schwannoma organoid to the proteomic profile of the original tumour.
Transcriptomic	10 years	Comparing the transcriptomic profile of the vestibular schwannoma organoid to the transcriptomic profile of the original tumour.

Trial Locations

Locations (2)

Maastro; 🇳🇱 Maastricht, Limburg, Netherlands

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands