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Trial Title:
Vestibular Schwannoma Organoids
NCT ID:
NCT05786144
Condition:
Vestibular Schwannoma
Conditions: Official terms:
Neurilemmoma
Neuroma, Acoustic
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Patients with a supsicion for vestibular schwannoma on an MRI for which surgery was
indicated (approximately 10 per year in Maastricht).
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Maastro
Address:
City:
Maastricht
Zip:
6229ET
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Chantal Overhof, Bec
Phone:
+31 88 44 55863
Email:
chantal.overhof@maastro.nl
Contact backup:
Last name:
Ann Claessens
Phone:
+31 88 44 55 863
Email:
ann.claessens@maastro.nl
Investigator:
Last name:
Marc Vooijs, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Maastricht University Medical Center
Address:
City:
Maastricht
Zip:
6229HX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Chantal Overhof, Bec
Phone:
+31 88 4455863
Email:
chantal.overhof@maastro.nl
Contact backup:
Last name:
Ann Claessens
Phone:
+31 88 44 55 863
Email:
ann.claessens@maastro.nl
Investigator:
Last name:
Koos Hovinga
Email:
Principal Investigator
Start date:
June 1, 2020
Completion date:
June 1, 2030
Lead sponsor:
Agency:
Maastricht Radiation Oncology
Agency class:
Other
Collaborator:
Agency:
Maastricht University Medical Center
Agency class:
Other
Source:
Maastricht Radiation Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05786144
