Intraoperatively Observed Site of Origin and Growth Pattern of Medulloblastoma
NCT ID: NCT06814353
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
100 participants
OBSERVATIONAL
2024-03-01
2026-03-31
Brief Summary
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The main questions it aims to answer are:
* Is there a significant difference between the intraoperatively observed site of origin and the preoperatively or postoperatively radiologically assessed site of origin of medulloblastoma?
* How does the intraoperatively observed site of origin align with the site of origin associated with the molecular group based on the developmental cell lineage concept of medulloblastoma?
* Does incorporating the intraoperatively observed site of origin as a feature improve the predictive accuracy of radiomic models for molecular group classification?
Participants will:
* Undergo intraoperative assessment of site of origin and growth pattern by an experienced pediatric neurosurgeon.
* Have their site of origin and growth pattern evaluated on pre- and postoperative magnetic resonance imaging by an neuroradiologist with expertise in pediatric brain tumors.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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WNT-MB
Patients with a medulloblastoma of the subgroup MB, WNT(Wingless)-activated according to the WHO classification 2021.
Intraoperative assessment of the site of origin and growth pattern
The assessment of the epicenter and extension and therefore the assumed origin of tumor growth is conducted by an experienced pediatric neurosurgeon blinded to group allocation based on the intraoperative impression. The anatomical features and site of origin are systematically documented on the surgical form in all cases of this study.
SHH-MB
Patients with a medulloblastoma of the subgroup MB, SHH (Sonic Hedgehog)-activated according to the World Health Organization (WHO) classification 2021. This subgroup can be further differentiated into SHH-activated (SHH-MB) TP53-wildtype and MB, SHH-activated TP53-mutant.
Intraoperative assessment of the site of origin and growth pattern
The assessment of the epicenter and extension and therefore the assumed origin of tumor growth is conducted by an experienced pediatric neurosurgeon blinded to group allocation based on the intraoperative impression. The anatomical features and site of origin are systematically documented on the surgical form in all cases of this study.
Group 3 and Group 4
Patients with a medulloblastoma of the subgroup MB, non-WNT/non-SHH activated MB (Group 3 and 4) according to the WHO classification 2021.
Intraoperative assessment of the site of origin and growth pattern
The assessment of the epicenter and extension and therefore the assumed origin of tumor growth is conducted by an experienced pediatric neurosurgeon blinded to group allocation based on the intraoperative impression. The anatomical features and site of origin are systematically documented on the surgical form in all cases of this study.
Interventions
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Intraoperative assessment of the site of origin and growth pattern
The assessment of the epicenter and extension and therefore the assumed origin of tumor growth is conducted by an experienced pediatric neurosurgeon blinded to group allocation based on the intraoperative impression. The anatomical features and site of origin are systematically documented on the surgical form in all cases of this study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Both pediatric patients (aged \< 18 years at the time of diagnosis) and adult patients (aged \> 18 years at the time of diagnosis)
Exclusion Criteria
* If an intraoperative complication occurs (e.g. bleeding) which impairs visibility of the neuroanatomic structures and does not allow an accurate assessment of the STO, the patient is excluded.
* If the histopathological and molecular analysis does not confirm the diagnosis of a MB, the patient has to be excluded as well.
ALL
No
Sponsors
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Medical University of Vienna
OTHER
University Hospital Tuebingen
OTHER
Utrecht University
OTHER
Charite University, Berlin, Germany
OTHER
Christian Dorfer
OTHER
Responsible Party
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Christian Dorfer
Assoc. Prof. Priv.-Doz. Dr. Christian Dorfer, MBA
Locations
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Department of Neurosurgery, Medical University of Vienna
Vienna, Vienna, Austria
Department of Neurosurgery, Charité Berlin
Berlin, , Germany
Section of Pediatric Neurosurgery, University Hospital of Tuebingen
Tübingen, , Germany
Department of Neurosurgery, Princess Maxima Centre for Pediatric Oncology
Utrecht, , Netherlands
Countries
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Other Identifiers
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ISOP (EK 1967/2023)
Identifier Type: -
Identifier Source: org_study_id
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