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

Pediatric Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351035
• Other study ID #: CNOG-MC001
• Status: Completed
• Start date: October 27, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: August 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4303
• Est. completion date: August 31, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Brain Tumor
• Brain Neoplasms
• Central Nervous System Neoplasms
• Malignant Brain Tumor
• Neoplasms
• Pediatric Brain Tumor
• Tumors, Central Nervous System

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing
China	the First Bethune Hospital of Jilin University	Ch'ang-ch'un	Jilin
China	Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Army Medical Center of PLA	Chongqing	Chongqing
China	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing
China	the First Hospital Affiliated To Army Medical University	Chongqing	Chongqing
China	900 Hospital of the Joint Logistics Team of PLA	Fuzhou	Fujian
China	the First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Guangdong 999 Brain Hospital	Guangzhou	Guangdong
China	Affiliated Hospital of Guilin Medical University	Guilin	Guangxi Zhuang Autonomous Region
China	the Children's Hospital, Zhejiang University School of Medicine	Hanzhou	Zhejiang
China	the First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Anhui Provincial Children's Hospital	Hefei	Anhui
China	Qilu Children's Hospital of Shandong University	Jinan	Shandong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Kunming Children's Hospital	Kunming	Yunnan
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
China	Jiangxi Provincial Children's Hospital	Nanchang	Jiangxi
China	the First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Children's Hospital of Fudan University	Shanghai	Shanghai
China	Huashan Hospital, Fudan University	Shanghai	Shanghai
China	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shengjing Hospital Affiliated to China Medical University	Shenyang	Liaoning
China	the Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	the First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	the Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	the Children's Hospital of Shanxi Province	Taiyuan	Shanxi
China	People's Hospital of Xinjiang Uygur Autonomous Region	Urumqi	Xinjiang Uygur Autonomous Region
China	Renmin Hospital of Wuhan University / Hubei General Hospital	Wuhan	Hubei
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology	Wuhan	Hubei
China	Xi'an Children's Hospital	Xi'an	Shaanxi
China	Xijing Hospital of Air Force Military Medical University	Xi'an	Shaanxi
China	the General Hospital of Ningxia Medical University	Yinchuan	Ningxia Hui Autonomous Region
China	Children's Hospital Affiliated to Zhengzhou University	Zhengzhou	Henan
China	the Fifth Affiliated Hospital of Zhengzhou University	Zhengzhou	Hunan
China	the Third Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Affiliated Hospital of Zunyi Medical College	Zunyi	Guizhou

Sponsors (2)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	CNOG-MC001 Collaborative Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline information of children with CNS tumours	Baseline information including gender, age, and institutional geographic data are required for epidemiology analysis.	2 years
Primary	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	Overall Survival	Available overall survival data with post surgery treatments records of enrolled cases is preferred but not mandatory for outcome analysis.	1 year
Secondary	Progression Free Survival	Progression free survival data is preferred but not mandatory for outcome analysis.	1 year