Skip to content

Establishment and Clinical Application of Risk Classification Model Based on Molecular Typing of Medulloblastoma in Children

Establishment and Clinical Application of Risk Classification Model Based on Molecular Typing of Medulloblastoma in Children

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05406947
Enrollment
350
Registered
2022-06-07
Start date
2023-01-30
Completion date
2030-12-31
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medulloblastoma, Childhood

Keywords

Medulloblastoma, Glioma, Medulloblastoma, Childhood, Recurrent, Neuroepithelioma

Brief summary

The purpose of this study:(1) Development of a new risk classification model for childhood medulloblastoma. (2) Evaluation and improvement of existing individualized treatment protocols.

Detailed description

Medulloblastoma (medulloblastoma, MB) is the most common intracranial malignant tumor in children, accounting for 20% of all central nervous system tumors in children, seriously affecting the quality of life and life span of children. Based on a retrospective analysis of previous MB cases in our center, we found that the clinical prognosis of previous MB patients in our center was worse than that in foreign countries, with an overall five-year survival rate of about 65%, and nearly 30% of the patients had tumor recurrence and metastasis within 2 years after the operation, and the prognosis was poor. We analyzed the possible reasons as follows: (1) the compliance to radiotherapy and chemotherapy in children with MB in our center was poor, and some of the patients only completed radiotherapy and had poor compliance with chemotherapy; (2) due to the lack of family doctor system, the tumor of the newly diagnosed patients was huge, which seriously affected the important brain function and clinical prognosis; (3) the patients were not followed up strictly and regularly after operation to monitor tumor recurrence, which led to poor treatment effect after recurrence. (4) the unified treatment standard has not been formed yet, and the treatment mode for patients is complex. As the largest neurosurgery and pediatric neurosurgery center in China, the center intends to prospectively establish a high-quality homogeneous MB observation cohort in children, make use of the center's case resources and biological sample processing advantages, and carry out accurate treatment research on children's MB through regular follow-up and systematic management of the clinical cohort.

Interventions

OTHERProspective observational study, no intervention

Prospective observational study, no intervention

Sponsors

Beijing Neurosurgical Institute
CollaboratorOTHER
Beijing Children's Hospital
CollaboratorOTHER
Beijing Shijitan Hospital, Capital Medical University
CollaboratorOTHER
Xuanwu Hospital, Beijing
CollaboratorOTHER
Peking University Third Hospital
CollaboratorOTHER
Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

* Age 0.5-18 years (except neonates). * Pathologically confirmed medulloblastoma. * Not having received any other relevant treatment before surgery. * Completion of enhanced MRI of the head and spinal cord. * Availability of tumor samples and determination of molecular typing. * Postoperative KPS score ≥ 70. * Voluntary enrollment in the group and the ability to receive long-term follow-up. * The patient or the patient's family voluntarily signed the informed consent form.

Exclusion criteria

* Patients who have recently received other drugs or radiation therapy. * Patients suffering from acute or chronic infectious diseases * Patients suffering from neurological or psychiatric diseases or mental disorders that cannot be easily controlled, or poor compliance. * Patients who cannot receive enhanced MRI scans. * Other conditions that the investigator believes make the patient unfit to participate in this trial.

Design outcomes

Primary

MeasureTime frameDescription
Overall survival2022-2030the time from operation to death
Quality of life scale2022-2030A scale for evaluating the quality of life of patients after operation
Adjunctive treatment2022-2030Patients receive postoperative radiotherapy or chemotherapy
Molecular typing2022-2030Medulloblastoma can be classified into four molecular types: WNT, SHH, G3 and G4.
Progression free survival2022-2030The time from operation to disease progression

Secondary

MeasureTime frameDescription
BMI2022-2030weight and height will be combined to report BMI in kg/m\^2
Age at diagnosis2022-2030

Contacts

Primary Contactyongji TIAN, MD
tianyongji@bjtth.org15801593549

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026