National Wide Cross-sectional Study in Paediatric Central Nervous System Tumours in China -- the CNOG-MC001 Registry
Retrospective, Multi-center Cross-sectional Study on Paediatric Central Nervous Systerm Tumours by CNOG-MC001 Collaborative Group
1 other identifier
observational
4,303
1 country
38
Brief Summary
Tumours of central nervous system (CNS) is the most common type of solid tumour in childhood. In China, there is limited epidemiology information. Released data from Chinese CDC did not include types of CNS tumours and geographic contribution. As the Children's Neuro-Oncology Group (CNOG) was established in China in May 2017, it makes studies from multiple centers in children's brain tumors become practical. This retrospective cross-sectional study was aligned on CNOG annual meeting in 2018 and research group was named as CNOG-MC001 (MC, multicenter) collaborative group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Typical duration for all trials
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2018
CompletedFirst Submitted
Initial submission to the registry
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
April 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedSeptember 8, 2021
August 1, 2021
2.7 years
April 16, 2020
August 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Baseline information of children with CNS tumours
Baseline information including gender, age, and institutional geographic data are required for epidemiology analysis.
2 years
Tumour type and anatomic location
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.
2 year
Secondary Outcomes (2)
Overall Survival
1 year
Progression Free Survival
1 year
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
Newly diagnosed paediatric (0-18 y/o) CNS tumous in period of Jan.1st 2016 to Dec.31st 2017, with sufficient baseline data and clear pathological diagnosis according to classification of CNS tumours - WHO 2016 version (for exceptions please refer to eligibility criteria)
You may qualify if:
- patients who were newly diagnosed with CNS tumour admitted for in-patient treatments during period of Jan.1st 2016 to Dec. 31st 2017
- patients who were less than 18 year-old at diagnosis
- patients with available mandatory information as age, gender during enrollment
- patients must have pathological diagnosis of tumours, which followed 2016 edition of the World Health Organization (WHO) Classification of Tumours of the Central Nervous System (CNS), except the following conditions:
- Diffuse Intrinsic Pontine Glioma (DIPG) according to classic symptoms and typical MRI
- confirmed NF1 patients with classic symtoms and MRI representing Optic Pathway Glioma (OPG) with no surgical treatment indications will be marked as "pilocytic astrocytoma"
- patients with newly diagnosed recurrence or metastasis of previously confirmed (before Jan.1st 2016) Embryonal Tumours (medulloblastoma, emryonal tumour with multilayered rosettes - C19MC altered, atypical teratoid / rhabdoid tumour / others) and high grade gliomas (glioblastoma, anaplastic astrocytoma) that were unwilling to recieve second surgical treatment / inoperable / without surgical indication, will be marked as original diagnosis
- patients with newly diagnosed relapse of previously confirmed (before Jan.1st 2016) low grade glioma (defined as pilocytic astrocytoma, diffuse astrocytoma, pilomyxoid astrocytoma, pleomorphic xanthoastrocytoma, subependymal giant cell astrocytoma, oligodendroglioma, oligoastrocytoma, ganglioglioma, desmoplastic infantile astrocytoma and ganglioglioma, dysembryoplastic neuroepithelial tumour, papillary glioneuronal tumour, rosette-forming glioneuronal tumour of the fourth ventricle, angiocentric glioma, dysplastic cerebellar gangliocytoma, extraventricular neurocytoma, cerebellar liponeurocytoma, and central neurocytoma) and ependymal tumours in cross-sectional period, who were unwilling to be operated / inoperable / without surgical indication, will be marked as original diagnosis
- clinical, image and pathology data of patients with unidentified pathological diagnosis from member sites of CNOG-MC001 collaborative group will be sent to study center for reviewing; cases with unidentifiable diagnosis after center review and alignment with CNOG-MC001 sites will be marked as "unknown"
You may not qualify if:
- confirmed CNS metatasis patients whose tumour tissues were obtained from other systems other than CNS will be excluded
- patients with newly diagnosed recurrence or metastasis of previously confirmed CNS Tumours, will be excluded when primary tumour diagnosis and progression time points were both in cross-sectional period; these patients will be only enrolled as "newly diagnosed cases with primary tumours" and recorded as "progressed in follow-up" in follow-up data sheet
- patients with newly diagnosed relapse of previously confirmed (before Jan.1st 2016) low grade glioma and ependymal tumours, who were unwilling to be operated / inoperable, and were suspected as malignant transformation, will be excluded due to lack of pathological diagnosis
- patients with insufficient or inconsistant data (e.g: patient diagnosed with primary medulloblastoma with tumour located in cerebral) will be excluded in center review after consulting with data-upload institutions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Anhui Provincial Children's Hospital
Hefei, Anhui, 230051, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014, China
the First Hospital Affiliated To Army Medical University
Chongqing, Chongqing Municipality, 400038, China
Army Medical Center of PLA
Chongqing, Chongqing Municipality, 400042, China
the First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350001, China
900 Hospital of the Joint Logistics Team of PLA
Fuzhou, Fujian, 350025, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
Guangdong 999 Brain Hospital
Guangzhou, Guangdong, 510510, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001, China
Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou, 563000, China
the Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
the First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Children's Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan, 450006, China
the Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430022, China
Renmin Hospital of Wuhan University / Hubei General Hospital
Wuhan, Hubei, 430071, China
the Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Hunan, 450014, China
the Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, 330006, China
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
the First Bethune Hospital of Jilin University
Ch’ang-ch’un, Jilin, 130021, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, 110004, China
the General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Xi'an Children's Hospital
Xi'an, Shaanxi, 710003, China
Xijing Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 710032, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Qilu Children's Hospital of Shandong University
Jinan, Shandong, 250021, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200086, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
the Children's Hospital of Shanxi Province
Taiyuan, Shanxi, 030013, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang Uygur Autonomous Region, 830001, China
Kunming Children's Hospital
Kunming, Yunnan, 650100, China
the Children's Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang, 310003, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jie MA, M.D., Ph.D.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Dept Pediatric Neurosurgery
Study Record Dates
First Submitted
April 16, 2020
First Posted
April 17, 2020
Study Start
October 27, 2018
Primary Completion
July 1, 2021
Study Completion
August 31, 2021
Last Updated
September 8, 2021
Record last verified: 2021-08