Status:
UNKNOWN
Children's and Adolescents' Medulloblastoma Molecular Subgroups in China
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
Children's Neuro-Oncology Group (CNOG)
Conditions:
Medulloblastoma, Childhood
Eligibility:
All Genders
Up to 18 years
Brief Summary
Recently, diagnosis and treatments for medulloblastoma becomes more complicated than before since the new World Health Organization (WHO) diagnosis criteria has put molecular marker onto an ever impor...
Detailed Description
Studies discovered that medulloblastoma is a group of tumors with different pathogenesis through different pathways, and majorly can be divided into four molecular subgroups. Moreover, multicenter ret...
Eligibility Criteria
Inclusion
- Participants must have classical histology posterior fossa medulloblastoma as determined by institutional neuro-pathological evaluation.
- Participants must have tumor tissue samples (either paraffin embedded tissue block or frozen tissue) for NanoString test for distinguishing the molecular subgroups of medulloblastoma in Xinhua hospital affiliated to Shanghai Jiaotong University School of Medicine (SHXH).
- Participants must provide tumor tissue samples (either paraffin embedded tissue block or frozen tissue) for immunohistochemistry assessment in verifying the molecular subgroups of medulloblastoma, or conduct the same immunohistochemistry test according to central analysis in SHXH, and send the slides to SHXH for center reviewing.
- Diagnostic imaging (pre and post operation (OP) contrast MRI or CT, Post-OP imaging conducted within 72 hours, no later than 14 days) must be forwarded to SHXH for central review to confirm eligibility.
- Sufficient pathologic material must be available for central analysis and review in SHXH.
- The patients must have no previous radiotherapy or chemotherapy other than corticosteroids.
- Ability to understand and willingness to comply with follow-up visits.
- Life expectancy more than 4 weeks.
Exclusion
- Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids.
- Tumor tissue sample not available for biological studies (from the initial diagnosis and/or relapse).
- Clinically significant unrelated systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would compromise the patient's ability to tolerate standard treatment or would likely interfere with study results.
- Patients obtained no radiation and/or chemo therapies are not excluded in this study since the nature history of the disease will also be evaluated.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03288168
Start Date
September 1 2017
End Date
June 30 2021
Last Update
April 17 2020
Active Locations (9)
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1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
2
Fuzhou General Hospital of Nanjing Military Region
Fuzhou, Fujian, China, 350100
3
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
4
Guangdong 999 Brain Hospital
Guangzhou, Guangdong, China, 510510