National Wide Cross-sectional Study in Paediatric Central Nervous System Tumours in China -- the CNOG-MC001 Registry

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT04351035

Collaborator

CNOG-MC001 Collaborative Group (Other)

4,303

Enrollment

Locations

34.1

Actual Duration (Months)

113.2

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tumors, Central Nervous System Pediatric Brain Tumor Malignant Brain Tumor Benign Brain Tumor	Procedure: Tumour resection

Detailed Description

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

4303 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Retrospective, Multi-center Cross-sectional Study on Paediatric Central Nervous Systerm Tumours by CNOG-MC001 Collaborative Group

Actual Study Start Date :

Oct 27, 2018

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Baseline information of children with CNS tumours [2 years]
Baseline information including gender, age, and institutional geographic data are required for epidemiology analysis.
Tumour type and anatomic location [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.

Secondary Outcome Measures

Overall Survival [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 [1 year]
Progression free survival data is preferred but not mandatory for outcome analysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anhui Provincial Children's Hospital	Hefei	Anhui	China	230051
2	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing	China	100070
3	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing	China	400014
4	the First Hospital Affiliated To Army Medical University	Chongqing	Chongqing	China	400038
5	Army Medical Center of PLA	Chongqing	Chongqing	China	400042
6	the First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	China	350001
7	900 Hospital of the Joint Logistics Team of PLA	Fuzhou	Fujian	China	350025
8	Lanzhou University Second Hospital	Lanzhou	Gansu	China	730030
9	Guangdong 999 Brain Hospital	Guangzhou	Guangdong	China	510510
10	Affiliated Hospital of Guilin Medical University	Guilin	Guangxi Zhuang Autonomous Region	China	541001
11	Affiliated Hospital of Zunyi Medical College	Zunyi	Guizhou	China	563000
12	the Second Hospital of Hebei Medical University	Shijiazhuang	Hebei	China	050000
13	the First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150001
14	Children's Hospital Affiliated to Zhengzhou University	Zhengzhou	Henan	China	450006
15	the Third Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450052
16	Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology	Wuhan	Hubei	China	430022
17	Renmin Hospital of Wuhan University / Hubei General Hospital	Wuhan	Hubei	China	430071
18	the Fifth Affiliated Hospital of Zhengzhou University	Zhengzhou	Hunan	China	450014
19	the Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215004
20	the First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215006
21	Jiangxi Provincial Children's Hospital	Nanchang	Jiangxi	China	330006
22	the First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China	330006
23	the First Bethune Hospital of Jilin University	Ch'ang-ch'un	Jilin	China	130021
24	Shengjing Hospital Affiliated to China Medical University	Shenyang	Liaoning	China	110004
25	the General Hospital of Ningxia Medical University	Yinchuan	Ningxia Hui Autonomous Region	China	750004
26	Xi'an Children's Hospital	Xi'an	Shaanxi	China	710003
27	Xijing Hospital of Air Force Military Medical University	Xi'an	Shaanxi	China	710032
28	Qilu Hospital of Shandong University	Jinan	Shandong	China	250012
29	Qilu Children's Hospital of Shandong University	Jinan	Shandong	China	250021
30	Huashan Hospital, Fudan University	Shanghai	Shanghai	China	200040
31	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai	China	200086
32	Children's Hospital of Fudan University	Shanghai	Shanghai	China	201102
33	the Children's Hospital of Shanxi Province	Taiyuan	Shanxi	China	030013
34	Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital	Chengdu	Sichuan	China	610072
35	Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan	China	646000
36	People's Hospital of Xinjiang Uygur Autonomous Region	Urumqi	Xinjiang Uygur Autonomous Region	China	830001
37	Kunming Children's Hospital	Kunming	Yunnan	China	650100
38	the Children's Hospital, Zhejiang University School of Medicine	Hanzhou	Zhejiang	China	310003