National Wide Cross-sectional Study in Paediatric Central Nervous System Tumours in China -- the CNOG-MC001 Registry
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|ClinicalTrials.gov Identifier: NCT04351035|
Recruitment Status : Active, not recruiting
First Posted : April 17, 2020
Last Update Posted : April 20, 2020
|Condition or disease||Intervention/treatment|
|Tumors, Central Nervous System Pediatric Brain Tumor Malignant Brain Tumor Benign Brain Tumor||Procedure: Tumour resection|
CNS tumours are mostly seen solid tumours in childhood , as the second common malignancy following leukemia in children. The annual age-standardized incidence rate per 1,000,000 person-years (ASR) of CNS tumour in international children's cancer incidence study is 20-30. In Asia, ASR of paediatric CNS tumours is around 15.0-24.9 in Japan, Korea, Singapore. For Chinese races including mainland of China, Taiwan and Hong Kong, ASRs of paediatric CNS tumour are 15.0, 17.4 and 23.8.
In 2017 in Shanghai, Children's Neuro-Oncology Group (CNOG) was found in 5th CSPN (Chinese Society of Pediatric Neurosurgery) / 9th CPNF (China Pediatric Neurosurgery Forum) conference, with 35 founding member institutions and 30 founding observation member institutions in mainland of China. Based on this progress, national wide registry (CNOG-MC001) was settled to obtain basic information about CNS tumour cases, combined with available epidemiology data from publications to assess current medical situation on paediatric CNS tumours in China. The protocol of CNOG-MC001 was aligned by CSPN and CNOG member institutions in CNOG annual meeting in 2018 and the study ofiicially started right after the meeting on 20181027.
The first step of this study is a national wide pre-survey to all 35 CNOG member institutions and other 22 CSPN members. The pre-survey data sheet included number of annual surgically treated paediatric CNS tumour cases (age ranging from 0 to 18 years old, classified by WHO Classification of Tumours of the Central Nervous System 2016 version), to assess the proper sites to be involved in this study. After retrieving the pre-survey results, large-scale, detailed case data sheets will be sent to participating institutions as members of CNOG-MC001 collaborative group.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||4059 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Retrospective, Multi-center Cross-sectional Study on Paediatric Central Nervous Systerm Tumours by CNOG-MC001 Collaborative Group|
|Actual Study Start Date :||October 27, 2018|
|Actual Primary Completion Date :||June 24, 2019|
|Estimated Study Completion Date :||May 1, 2020|
Children with CNS tumours
Patients newly diagnosed with CNS tumours in children younger than 18 y/o, who were under in-patient treatment, were labeled as candidate cases in the CNOG-MC001 cohort for reviewing.
Procedure: Tumour resection
It is mandatory that patients recieve surgical treatment for pathological diagnosis of CNS tumours in enrolled patients. Surgical resection of tumours could be regarded as total / subtotal / partial resection and biopsy.
- Baseline information of children with CNS tumours [ Time Frame: 2 years ]Baseline information including gender, age, and institutional geographic data are required for epidemiology analysis.
- Tumour type and anatomic location [ Time Frame: 2 year ]Tumour type according to 2016 edition of the World Health Organization (WHO) Classification of Tumours of the Central Nervous System (CNS) is mandatory for epidemiology analysis.
- Overall Survival [ Time Frame: 1 year ]Available overall survival data with post surgery treatments records of enrolled cases is preferred but not mandatory for outcome analysis.
- Progression Free Survival [ Time Frame: 1 year ]Progression free survival data is preferred but not mandatory for outcome analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351035
|Study Chair:||Jie MA, M.D., Ph.D.||Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine|