Vestibular Schwannoma Organoids

Vestibular Schwannoma Clinical Trial

Official title:

Vestibular Schwannoma Stem Cell Organoids

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786144
• Other study ID #: Schwannoma organoids
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: June 1, 2030

Study information

• Verified date: April 2024
• Source: Maastricht Radiation Oncology
• Contact: Chantal Overhof, Bec.
• Phone: +31 88 4455863
• Email: chantal.overhof[@]maastro.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2030
• Est. primary completion date: June 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg
Netherlands	Maastro	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 years
Secondary	Phenotype	Comparing the phenotypical profile of the vestibular schwannoma organoid to the phenotypical profile of the original tumour.	10 years
Secondary	Genetic	Comparing the genetic profile of the vestibular schwannoma organoid to the genetic profile of the original tumour.	10 years
Secondary	Epigenetic	Comparing the epigenetic profile of the vestibular schwannoma organoid to the epigenetic profile of the original tumour.	10 years
Secondary	Proteomic	Comparing the proteomic profile of the vestibular schwannoma organoid to the proteomic profile of the original tumour.	10 years
Secondary	Transcriptomic	Comparing the transcriptomic profile of the vestibular schwannoma organoid to the transcriptomic profile of the original tumour.	10 years