Clinical trial NCT04351035: National Wide Cross-sectional Study in Paediatric Central Nervous System Tumours in China -- the CNOG-MC001 Registry
Official title: Retrospective, Multi-center Cross-sectional Study on Paediatric Central Nervous Systerm Tumours by CNOG-MC001 Collaborative Group
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tumors, Central Nervous System
Pediatric Brain Tumor
Malignant Brain Tumor
Benign Brain Tumor
Keywords: national wide
cross-sectional
retrospective
CNOG-MC001
pediatric
central nervous system tumor
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: CNOG-MC001 Collaborative Group
First posted: 2020-04-17
Enrollment: 4303
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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.

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.

Eligibility criteria: 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:

  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:

* 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

Primary outcomes:
measure: Baseline information of children with CNS tumours
timeFrame: 2 years
measure: Tumour type and anatomic location
timeFrame: 2 year
Secondary outcomes:
measure: Overall Survival
timeFrame: 1 year
measure: Progression Free Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Children's Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: the First Hospital Affiliated To Army Medical University
state: Chongqing
city: Chongqing
country: China
facility: Army Medical Center of PLA
state: Chongqing
city: Fuzhou
country: China
facility: the First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Fuzhou
country: China
facility: 900 Hospital of the Joint Logistics Team of PLA
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Guangzhou
country: China
facility: Guangdong 999 Brain Hospital
state: Guangdong
city: Guilin
country: China
facility: Affiliated Hospital of Guilin Medical University
state: Guangxi Zhuang Autonomous Region
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical College
state: Guizhou
city: Shijiazhuang
country: China
facility: the Second Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: the First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Children's Hospital Affiliated to Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: the Third Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University / Hubei General Hospital
state: Hubei
city: Zhengzhou
country: China
facility: the Fifth Affiliated Hospital of Zhengzhou University
state: Hunan
city: Suzhou
country: China
facility: the Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: the First Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Children's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: the First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Ch'ang-ch'un
country: China
facility: the First Bethune Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital Affiliated to China Medical University
state: Liaoning
city: Yinchuan
country: China
facility: the General Hospital of Ningxia Medical University
state: Ningxia Hui Autonomous Region
city: Xi'an
country: China
facility: Xi'an Children's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital of Air Force Military Medical University
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Qilu Children's Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: the Children's Hospital of Shanxi Province
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
state: Sichuan
city: Luzhou
country: China
facility: Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Urumqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang Uygur Autonomous Region
city: Kunming
country: China
facility: Kunming Children's Hospital
state: Yunnan
city: Hanzhou
country: China
facility: the Children's Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Jie MA, M.D., Ph.D.
role: STUDY_CHAIR
References: