Intraoperatively Observed Site of Origin and Growth Pattern of Medulloblastoma

Официальное название

An International Multicenter Prospective Cohort Study Investigating the Intraoperatively Observed Site of Origin and Growth Pattern of the Molecular Groups of Medulloblastoma

Обзор

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Rate of agreement between the intraoperatively observed site of origin and preoperatively radiologically assessed site of origin of medulloblastoma [Срок оценки: From enrollment to the end of treatment at 6 weeks]

Вторичные конечные точки (3)

• 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 [Срок оценки: From enrollment to the end of treatment at 6 weeks]
• The neurological outcome measured as KPS scores stratified by the intraoperatively observed site of origin [Срок оценки: From enrollment to the end of treatment at 6-weeks]
• Predictive accuracy of radiogenomic models [Срок оценки: From enrollment to the end of treatment at 6 weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 2 центра

• Department of Neurosurgery, Charité Berlin — Berlin
• Section of Pediatric Neurosurgery, University Hospital of Tuebingen — Tübingen

Австрия · 1 центр

• Department of Neurosurgery, Medical University of Vienna — Vienna

Нидерланды · 1 центр

• Department of Neurosurgery, Princess Maxima Centre for Pediatric Oncology — Utrecht

Идентификаторы

NCT: NCT06814353 · ISOP (EK 1967/2023)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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