Clinical trial NCT06814353: Intraoperatively Observed Site of Origin and Growth Pattern of Medulloblastoma
Official title: An International Multicenter Prospective Cohort Study Investigating the Intraoperatively Observed Site of Origin and Growth Pattern of the Molecular Groups of Medulloblastoma
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Medulloblastoma
Keywords: Medulloblastoma
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
name: University Hospital Tuebingen
name: Utrecht University
name: Charite University, Berlin, Germany
First posted: 2025-02-07
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Both adult and pediatric patients who undergo surgical resection of a histologically confirmed medulloblastoma at a center with expertise in pediatric neurosurgery

Brief summary: The goal of this observational study is to provide accurate and systematic data on the site of origin and growth pattern of medulloblastoma from a neurosurgical perspective. By integrating intraoperative, radiological and genetic classification data, this study will contribute to our current understanding of the development, site of origin and growth pattern of medulloblastoma and advance the predictive accuracy of radiogenomics models. Patients with histologically confirmed medulloblastoma who undergo surgical resection at a high-volume center with expertise in pediatric neurosurgery will be included.

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.


Eligibility criteria: Inclusion Criteria:

* Patients who are referred for surgical resection of a medulloblastoma at a hospital with expertise in pediatric neurooncology
* Both pediatric patients (aged \< 18 years at the time of diagnosis) and adult patients (aged \> 18 years at the time of diagnosis)

Exclusion Criteria:

* Patients who are preoperatively admitted with severe tumor hemorrhage accompanied by clinical deterioration are excluded because these patients frequently do not receive magnetic resonance imaging as would be necessary for the present study, and the intraoperative assessment of the STO is limited in accuracy due to decreased visibility caused by the intra- and extratumoral hemorrhage.
* 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.

Primary outcomes:
measure: Rate of agreement between the intraoperatively observed site of origin and preoperatively radiologically assessed site of origin of medulloblastoma
timeFrame: From enrollment to the end of treatment at 6 weeks
Secondary outcomes:
measure: The rate of agreement between the intraoperatively observed site of origin and the site of origin presumably associated with a molecular group (standard of reference) based on the developmental cell lineage concept of medulloblastoma
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: The neurological outcome measured as KPS scores stratified by the intraoperatively observed site of origin
timeFrame: From enrollment to the end of treatment at 6-weeks
measure: Predictive accuracy of radiogenomic models
timeFrame: From enrollment to the end of treatment at 6 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Neurosurgery, Medical University of Vienna
city: Berlin
country: Germany
facility: Department of Neurosurgery, Charité Berlin
city: Tuebingen
country: Germany
facility: Section of Pediatric Neurosurgery, University Hospital of Tuebingen
city: Utrecht
country: Netherlands
facility: Department of Neurosurgery, Princess Maxima Centre for Pediatric Oncology
Study officials:
References: