Genetic and Molecular Risk Profiles of Pediatric Malignant Brain Tumors in China

NCT05672043 | Recruiting

• 1 other identifier: 20221226
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Primary malignant central nervous system (CNS) tumors are the second most common childhood malignancies. Amongst, medulloblastomas are the most common malignant brain tumor of childhood and occur primarily in the cerebellum. According to molecular characteristics, medulloblastomas were classified into four subtypes: WNT, SHH, Group3 and Group4 and different prognosis were noticed between subgroups. Several genetic predispositions related to clinical outcome were also discovered and might influence the treatment of medulloblastomas as novel pharmaceutical targets. This study aims to investigate genetic and cellular profiles of pediatric brain malignancies, mostly medulloblastomas, and other central nervous system tumor based on WGS, RNA-seq, single-cell sequencing and spatial transcriptomics. We also aim to investigate the correlation between genetic characteristics and clinical prognosis.

Conditions

Medulloblastoma; Central Nervous System Tumor, Pediatric; Ependymoma; Germ Cell Tumor; Glioma; Brain Tumor, Pediatric

Keywords

medulloblastoma; pediatric brain tumor

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  5 years

Secondary Outcomes (1)

• Progression free survival

  5 years

Eligibility Criteria

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

Study Population

Children and adolescents aged between 0-18 years old, diagnosed with medulloblastoma or other malignant central nervous system tumors in participated institutions in mainland China, with available clinical records and tumor samples, fitting eligibility criteria, are enrolled in this study.

You may qualify if:

• \- Children and adolescents aged between 0-18 years old, diagnosed with medulloblastoma or other malignant central nervous system tumors including glioma, ependymoma, germ cell tumors,tuberous sclerosis, neuronal and neuronoglial tumors, choroid plexus tumors, atypical teratoid/rhabdoid tumors, ependymoblastoma, and medulloepithelioma;
• Patients must be eligible for and receive tumor resection;
• Histological examination by institutional neuro-pathological evaluation must confirmed the diagnosis of brain malignancies;
• Participants consent with joining the current study and comply with follow-up visits;
• The patients must have no previous radiotherapy or chemotherapy other than corticosteroids.

You may not qualify if:

• \- Patients with major perioperative complications which lead to significant and sudden deterioration;
• Patients with major systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) which might compromise the patient's ability to tolerate standard treatment or would likely interfere with overall prognosis;
• Patients with major adverse events or sudden deterioration irrelevant to the current study;
• Quality of tumor tissue sample did not meet the criterion for genetic sequencing and laboratory investigations;
• Patients who refuse to participate in the study or who request dropping out from the study

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hosiptal

Beijing, Beijing Municipality, 100050, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample; tumor tissue

MeSH Terms

Conditions

Medulloblastoma; Central Nervous System Neoplasms; Ependymoma; Neoplasms, Germ Cell and Embryonal; Glioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases

Study Officials

• Tao Jiang, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Jiang, MD

CONTACT

+8613501306106; doctorjiangtt@163.com

Yahui Zhao, MD

CONTACT

+8618519325917; yahuii.zhao@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: January 5, 2023

Record last verified: 2023-01

Locations

CN (1)