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

NCT05406947 | Not Yet Recruiting DMC

• 1 other identifier: ChiCTR2200058760
• Study Type: observational
• Target: 350
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Medulloblastoma, Childhood

Keywords

Medulloblastoma; Glioma; Medulloblastoma, Childhood, Recurrent; Neuroepithelioma

Outcome Measures

Primary Outcomes (5)

• Molecular typing

  Medulloblastoma can be classified into four molecular types: WNT, SHH, G3 and G4.

  2022-2030

• Overall survival

  the time from operation to death

  2022-2030

• Progression free survival

  The time from operation to disease progression

  2022-2030

• Quality of life scale

  A scale for evaluating the quality of life of patients after operation

  2022-2030

• Adjunctive treatment

  Patients receive postoperative radiotherapy or chemotherapy

  2022-2030

Secondary Outcomes (2)

• Age at diagnosis

  2022-2030

• BMI

  2022-2030

Study Arms (3)

Low risk group

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.

Other: Prospective observational study, no intervention

Middle risk group

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.

Other: Prospective observational study, no intervention

High risk group

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.

Other: Prospective observational study, no intervention

Interventions

Prospective observational study, no intervention OTHER

Prospective observational study, no intervention

High risk group; Low risk group; Middle risk group

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

350 medulloblastoma patients aged 0.5-18 years (except newborns)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Beijing Neurosurgical Institute: collaborator
• Beijing Children's Hospital: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator
• Xuanwu Hospital, Beijing: collaborator
• Peking University Third Hospital: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

In this study, clinical samples (blood, cerebrospinal fluid, and tumor samples) are collected in the clinical working environment, and the samples are mainly from tumor tissues that must be removed during the operation and blood used for blood matching. The collection of cerebrospinal fluid is the remaining sample for clinical laboratory testing, and the damage to the patient is minimal.

MeSH Terms

Conditions

Medulloblastoma; Glioma; Recurrence; Neuroectodermal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yongji Tian, MD

  Beijing TianTanHospital, China Capital Medical University

  PRINCIPAL INVESTIGATOR

• FU ZHAO, MD

  Beijing Neurosurgical Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yongji TIAN, MD

CONTACT

15801593549; tianyongji@bjtth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 7, 2022
• Study Start: January 30, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 8, 2023

Record last verified: 2023-02