NCT05786144

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

June 1, 2020

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

5.6 years

First QC Date

March 14, 2023

Last Update Submit

January 28, 2026

Conditions

Vestibular Schwannoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Phenotype

    10 years

  • Genetic

    10 years

  • Epigenetic

    10 years

  • Proteomic

    10 years

  • Transcriptomic

    10 years

Eligibility Criteria

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

You may qualify if:

  • MRI with suspicion for vestibular schwannoma
  • Indication for surgery in the skull base committee
  • years or older

You may not qualify if:

  • Refusal to participate
  • Younger than 18 years
  • Incapacitated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maastro

Maastricht, Limburg, 6229ET, Netherlands

Location

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumour tissue

MeSH Terms

Conditions

Neuroma, Acoustic

Condition Hierarchy (Ancestors)

NeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve DiseasesNervous System Diseases

Study Officials

  • Koos Hovinga

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

  • Marc Vooijs, MD, PhD

    Maastro

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 14, 2023

First Posted

March 27, 2023

Study Start

June 1, 2020

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

NL(2)