- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05672043
Genetic and Molecular Risk Profiles of Pediatric Malignant Brain Tumors in China (GRIPP)
Perspective Study on Genetic Predispositions and Clinical Prognosis of Children and Adolescents With Malignant Brain Neoplasms in China
Study Overview
Status
Detailed Description
This is an observational study including pediatric patients with medulloblastomas, and other central nervous system tumor who are eligible for surgical tumor resection.
Patients will be registered after histological diagnosis is made and meet the inclusion criteria. Epidemiological, histological and radiological information will be collected and Case report form (CRF) will be filled up by investigators. Patients will be follow up 3 months, 6 months, 1 year after surgery and every year afterwards by phone and at clinics. MRI contrast scans are required for each follow-up to assess progression, relapse or metastasis. Patients' neurological status and quality of life will be evaluated during follow-up.
Blood samples and tumor tissue will be collected during surgery. After registry, samples will be send for WGS, whole transcriptome resequencing, single-cell sequencing and spatial transcriptomics as appropriate. Clinical outcome and genetic profiles will be analyzed as appropriate to find out the potential pathogenic factors.
Medulloblastomas samples will be used for culturing primary cells and generating patient-derived xenografts in mice. The latter will be used for in vivo experiments of medulloblastoma pathophysiological mechanisms and pharmaceutical investigations.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Tao Jiang, MD
- Phone Number: +8613501306106
- Email: doctorjiangtt@163.com
Study Contact Backup
- Name: Yahui Zhao, MD
- Phone Number: +8618519325917
- Email: yahuii.zhao@hotmail.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100050
- Recruiting
- Beijing Tiantan Hosiptal
-
Contact:
- Tao Jiang
- Email: doctorjiangtt@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: 5 years
|
No sign of tumor relapse, metastasis or progression confirmed by MRI contrast examination during follow-up
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tao Jiang, MD, Beijing Tiantan Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroectodermal Tumors, Primitive
- Neoplasms
- Brain Neoplasms
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Ependymoma
- Medulloblastoma
Other Study ID Numbers
- 20221226
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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