- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03288168
Children's and Adolescents' Medulloblastoma Molecular Subgroups in China (CNOG-MB001)
Multi-center Retrospective Study on Clinical Features and Molecular Subgroups of Children and Adolescents With Medulloblastoma in China
Study Overview
Status
Conditions
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 retrospective studies from US, Canada and European Countries revealed that the molecular subgroup of medulloblastoma becomes an independent correlated risk factor for the patient outcomes. This finding made WHO classification of tumours of central nervous system consider the markers in molecular pathway be an ever important indicator in the new diagnosis criteria. In COG prospective studies for target therapies, subgroup distinguishing becomes indispensable, and the use of immunohistochemistry combined with NanoString, DNA methylation arrays or other molecular methods makes subgroup identification more reliable. In China, there are limited single institutional studies, which were all conducted by immunohistochemistry or polymerase chain reaction (PCR), on molecular sub-grouping of medulloblastoma, especially in pediatric patients. This multicenter retrospective study enrolls children and adolescents (0-18y/o) with primary medulloblastoma from CNOG member institutions across the country, with available paraffin embedded samples and reliable follow-up information, to assess the correlation of molecular subgroups of medulloblastoma and outcomes in Chinese population.
This multicenter study recruits eligible patients from CNOG member institutions. Data validation and verification is double conducted by each center and investigators in central data base. Case report form (CRF) was designed by principle investigator and will be modified in the period of uploading first 5 cases by each participated center. The estimated enrollment is 200 cases after sample size assessment. Descriptive statistical analysis, Two-Sample (Independent group) T-Test and one-way ANOVA will be used in epidemiological analysis. Cox-regression / Kaplan-Meier plot will be used in survival analysis. Chi-square test will be used to validate the test efficiency of immunohistochemistry and NanoString methods.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350005
- The First Affiliated Hospital of Fujian Medical University
-
Fuzhou, Fujian, China, 350100
- Fuzhou General Hospital of Nanjing Military Region
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Sun Yat-sen University Cancer Center
-
Guangzhou, Guangdong, China, 510510
- Guangdong 999 Brain Hospital
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Xijing Hospital, Fourth Military Medical University
-
-
Shandong
-
Liaocheng, Shandong, China, 252000
- Liaocheng People's Hospital
-
-
Shanghai
-
Shanghai, Shanghai, China, 200127
- Renji Hospital, Shanghai Jiaotong University School of Medicine
-
Shanghai, Shanghai, China, 200086
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
-
-
Shanxi
-
Taiyuan, Shanxi, China, 030012
- Shanxi Provincial People's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
0-18 y/o Patients with Medulloblastoma
Patients treated with comprehensive treatments including surgery, chemo-therapy with / without (less than 3 y/o) radiation, during the period of Jan 2008 and Dec 2012, whose tumor samples will be tested by NanoString and Histochemistry methods, are enrolled in this cohort group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: Follow-up for final survival period till 31 December 2017 or last available contact, whichever occurred first
|
The observation period of outcome started with the first medical record available on site till last contact available on site or the end of the observation period (31 December 2017), whichever occurred first.
|
Follow-up for final survival period till 31 December 2017 or last available contact, whichever occurred first
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event Free Survival
Time Frame: Follow-up for none-recurrence survival (metastasis/relapse) period till 31 December 2017 or last available contact, whichever occurred first.
|
The observation period of outcome started with the first medical record available on site till last contact available on site or the end of the observation period (31 December 2017), whichever occurred first.
|
Follow-up for none-recurrence survival (metastasis/relapse) period till 31 December 2017 or last available contact, whichever occurred first.
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Jie MA, MD, Phd, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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
Other Study ID Numbers
- XH-17-014
- CNOG-MB001 (OTHER: Children's Neuro-Oncology Group)
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.
Clinical Trials on Medulloblastoma, Childhood
-
Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingUntreated Childhood MedulloblastomaUnited States, Canada, Australia, New Zealand, Switzerland, Netherlands
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUntreated Childhood Medulloblastoma | Untreated Childhood Supratentorial Primitive Neuroectodermal TumorUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Childhood Medulloblastoma | Recurrent Childhood Ependymoma | Recurrent Childhood Anaplastic Astrocytoma | Recurrent Childhood Brain Stem Glioma | Recurrent Childhood Giant Cell Glioblastoma | Recurrent Childhood Glioblastoma | Recurrent Childhood Gliosarcoma | Recurrent Childhood OligodendrogliomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Childhood Medulloblastoma | Recurrent Ependymoma | Recurrent MedulloblastomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Childhood MedulloblastomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Childhood MedulloblastomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Childhood Medulloblastoma | Childhood High-grade Cerebral Astrocytoma | Recurrent Childhood Brain Stem Glioma | Recurrent Childhood Cerebellar Astrocytoma | Recurrent Childhood Cerebral Astrocytoma | Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor | Recurrent Childhood... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Childhood Medulloblastoma | Recurrent Childhood Ependymoma | Recurrent Childhood Brain Stem Glioma | Childhood Spinal Cord Neoplasm | Childhood Oligodendroglioma | Childhood Cerebral Anaplastic AstrocytomaUnited States
-
University of California, San FranciscoWashington University School of Medicine; University of Washington; Pacific Pediatric... and other collaboratorsRecruitingMedulloblastoma | Medulloblastoma, Childhood | Medulloblastoma RecurrentUnited States
-
Sabine Mueller, MD, PhDMayo Clinic; Vyriad, Inc.; No More Kids With Cancer; The Matthew Larson Foundation...CompletedMedulloblastoma Recurrent | Atypical Teratoid/Rhabdoid Tumor | Medulloblastoma, Childhood, RecurrentUnited States