National Wide Cross-sectional Study in Paediatric Central Nervous System Tumours in China -- the CNOG-MC001 Registry
NCT ID: NCT04351035
Last Updated: 2021-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4303 participants
OBSERVATIONAL
2018-10-27
2021-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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:
1. Diffuse Intrinsic Pontine Glioma (DIPG) according to classic symptoms and typical MRI
2. confirmed NF1 patients with classic symtoms and MRI representing Optic Pathway Glioma (OPG) with no surgical treatment indications will be marked as "pilocytic astrocytoma"
3. 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
4. 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"
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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CNOG-MC001 Collaborative Group
UNKNOWN
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Jie Ma, MD, PhD
Director of Dept Pediatric Neurosurgery
Principal Investigators
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Jie MA, M.D., Ph.D.
Role: STUDY_CHAIR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Anhui Provincial Children's Hospital
Hefei, Anhui, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
the First Hospital Affiliated To Army Medical University
Chongqing, Chongqing Municipality, China
Army Medical Center of PLA
Chongqing, Chongqing Municipality, China
the First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
900 Hospital of the Joint Logistics Team of PLA
Fuzhou, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Guangdong 999 Brain Hospital
Guangzhou, Guangdong, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou, China
the Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
the First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Children's Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan, China
the Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Renmin Hospital of Wuhan University / Hubei General Hospital
Wuhan, Hubei, China
the Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Hunan, China
the Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
the First Bethune Hospital of Jilin University
Ch’ang-ch’un, Jilin, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China
the General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Xi'an Children's Hospital
Xi'an, Shaanxi, China
Xijing Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Qilu Children's Hospital of Shandong University
Jinan, Shandong, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
the Children's Hospital of Shanxi Province
Taiyuan, Shanxi, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang Uygur Autonomous Region, China
Kunming Children's Hospital
Kunming, Yunnan, China
the Children's Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang, China
Countries
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Other Identifiers
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CNOG-MC001
Identifier Type: -
Identifier Source: org_study_id
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