Establishment and Clinical Application of Risk Classification Model Based on Molecular Typing of Medulloblastoma in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prospective observational study, no intervention.
- Who it may be relevant to
- Registry conditions: Medulloblastoma, Childhood. Basic parameters: 6 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Prospective observational study, no intervention
Prospective observational study, no intervention
Primary outcome measures
- Molecular typing [Time frame: 2022-2030]
- Overall survival [Time frame: 2022-2030]
- Progression free survival [Time frame: 2022-2030]
- Quality of life scale [Time frame: 2022-2030]
- Adjunctive treatment [Time frame: 2022-2030]
Secondary outcome measures (2)
- Age at diagnosis [Time frame: 2022-2030]
- BMI [Time frame: 2022-2030]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05406947 · ChiCTR2200058760