NCT06814353Enrolling by invitation
Intraoperatively Observed Site of Origin and Growth Pattern of Medulloblastoma
An International Multicenter Prospective Cohort Study Investigating the Intraoperatively Observed Site of Origin and Growth Pattern of the Molecular Groups of Medulloblastoma
Source: ClinicalTrials.gov · Last updated 7 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 26 Dec 2024
- Start date
- 1 Mar 2024
- Primary completion date
- Mar 2026
- Lead sponsor
- Christian Dorfer
- Diseases
- Childhood cancers
- NCT number
- NCT06814353
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Mar 2024 to the primary completion date, Mar 2026
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- If the histopathological and molecular analysis does not confirm the diagnosis of a MB, the patient has to be excluded as well.
Who the study is looking for
- 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)
Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurosurgery, Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Department of Neurosurgery, Charité Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Section of Pediatric Neurosurgery, University Hospital of Tuebingen Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Department of Neurosurgery, Princess Maxima Centre for Pediatric Oncology Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.