Actively Recruiting
Perspective Study on Genetic Predispositions and Clinical Prognosis of Children and Adolescents With Malignant Brain Neoplasms in China
Led by Beijing Tiantan Hospital · Updated on 2023-01-05
400
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary malignant central nervous system (CNS) tumors are the second most common cancers in children, with medulloblastomas being the most frequent malignant brain tumor in childhood, mainly located in the cerebellum. This research focuses on studying the genetic and cellular characteristics of pediatric brain tumors, especially medulloblastomas, by analyzing molecular subtypes and their relation to clinical outcomes. The study aims to explore genetic predispositions and their impact on prognosis and treatment options. This observational study includes children and adolescents diagnosed with medulloblastomas and other malignant CNS tumors who are undergoing surgical tumor removal. Blood and tumor tissue samples will be collected during surgery for various advanced genetic tests such as whole genome sequencing, RNA sequencing, single-cell sequencing, and spatial transcriptomics. Samples of medulloblastomas will also be used to grow cells and create animal models to study tumor behavior and test new drug approaches. Participants will be registered after diagnosis and followed up at 3 months, 6 months, 1 year, and annually thereafter through clinic visits and phone calls. Each follow-up will include MRI scans to monitor tumor progression, relapse, or spread, as well as assessments of neurological function and quality of life. Data collected will help researchers understand how genetic features relate to patient survival and disease progression over five years.
CONDITIONS
Brief Title
Genetic and Molecular Risk Profiles of Pediatric Malignant Brain Tumors in China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 scheduled to receive tumor resection surgery
- Histological examination by institutional neuro-pathological evaluation must confirm diagnosis of brain malignancies
- Participants and/or guardians must consent to join the study and agree to follow-up visits
- Patients must have no previous radiotherapy or chemotherapy other than corticosteroids
You will not qualify if you...
- Patients with major perioperative complications causing significant and sudden deterioration
- Patients with major systemic illness (such as serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that may prevent tolerating standard treatment or affect prognosis
- Patients with major adverse events or sudden deterioration unrelated to the current study
- Tumor tissue samples not meeting quality criteria for genetic sequencing and lab investigations
- Patients who refuse to participate or wish to withdraw from the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo surgical tumor resection during which blood samples and tumor tissue are collected for genetic and molecular analyses.
1 surgical visit (in-person)
Duration - Up to 5 years
Participants are followed up to monitor clinical outcomes including neurological status and quality of life, with MRI contrast scans to assess progression, relapse, or metastasis.
Follow-up visits at 3 months, 6 months, 1 year post-surgery, and annually thereafter (in-person and phone)
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hosiptal
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
Research Team
T
Tao Jiang, MD
Y
Yahui Zhao, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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