An observational study in Medulloblastoma, Central Nervous System Tumor, Pediatric and Ependymoma, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-01-05.
Sponsored by Beijing Tiantan Hospital · Observational
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.
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.
317 studies on the registry are indexed under Medulloblastoma; 51 are open to participants now.
This study's planned enrollment of 400 is above the median of 163 across 34 observational studies indexed under Medulloblastoma.
Browse Medulloblastoma studies →Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must be eligible for and receive tumor resection;
Histological examination by institutional neuro-pathological evaluation must confirmed the diagnosis of brain ;
Participants consent with joining the current study and comply with follow-up visits;
The patients must have no previous radiotherapy or chemotherapy other than .
Exclusion Criteria:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Overall Survival
Time frame: 5 years
Progression free survival
No sign of tumor relapse, metastasis or progression confirmed by MRI contrast examination during follow-up
Time frame: 5 years
Plan to share: Undecided
No publications or documents are linked to this record.
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