Vestibular Schwannoma Organoids

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05786144
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Maastricht Radiation Oncology
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Koos HovingaMarc Vooijs, MD, PhD
Principal Investigator Affiliation Maastricht University Medical CenterMaastro
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Vestibular Schwannoma
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Maastro, Maastricht, Limburg, Netherlands

Status

Recruiting

Address

Maastro

Maastricht, Limburg, 6229ET

Site Contact

Chantal Overhof, Bec

[email protected]

+31 88 44 55863

Maastricht University Medical Center, Maastricht, Limburg, Netherlands

Status

Recruiting

Address

Maastricht University Medical Center

Maastricht, Limburg, 6229HX

Site Contact

Chantal Overhof, Bec

[email protected]

+31 88 4455863

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