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

Capital Medical University

Status: Not yet enrolling

Conditions: Medulloblastoma, Childhood

Treatments: Other: Prospective observational study, no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05406947

ChiCTR2200058760

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

350 participants in 3 patient groups

Low risk group

Description:

Based on clinicopathological diagnosis and molecular pathological diagnosis, the children were classified into low risk groups, individualized radiotherapy and chemotherapy plan was made, and a perfect registration and follow-up system was established.

Treatment:

Other: Prospective observational study, no intervention

Middle risk group

Description:

Based on clinicopathological diagnosis and molecular pathological diagnosis, the children were classified into middle risk groups, individualized radiotherapy and chemotherapy plan was made, and a perfect registration and follow-up system was established.

Treatment:

Other: Prospective observational study, no intervention

High risk group

Description:

Based on clinicopathological diagnosis and molecular pathological diagnosis, the children were classified into high risk groups, individualized radiotherapy and chemotherapy plan was made, and a perfect registration and follow-up system was established.

Treatment:

Other: Prospective observational study, no intervention