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Tumors, Central Nervous SystemNCT04351035

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

An observational study of Tumors, Central Nervous System and Pediatric Brain Tumor, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 38 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 18 years
What is being tested?
Tumour resection
Type of treatment
Surgery or procedure
How many people
4,303 participants
Where
38 sitesChina
Study dates
27 Oct 2018to 31 Aug 2021
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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)

Who may be able to join

  • 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"
Show all 9Show fewer
  • 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"

Who cannot join

  • 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

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

China38 sites

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070

  • the First Bethune Hospital of Jilin University

    Ch’ang-ch’un, Jilin, 130021

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400014

  • the First Hospital Affiliated To Army Medical University

    Chongqing, Chongqing Municipality, 400038

  • Army Medical Center of PLA

    Chongqing, Chongqing Municipality, 400042

  • the First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350001

  • 900 Hospital of the Joint Logistics Team of PLA

    Fuzhou, Fujian, 350025

  • Guangdong 999 Brain Hospital

    Guangzhou, Guangdong, 510510

  • Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541001

  • the Children's Hospital, Zhejiang University School of Medicine

    Hanzhou, Zhejiang, 310003

  • the First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Anhui Provincial Children's Hospital

    Hefei, Anhui, 230051

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Qilu Children's Hospital of Shandong University

    Jinan, Shandong, 250021

  • Kunming Children's Hospital

    Kunming, Yunnan, 650100

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

  • Jiangxi Provincial Children's Hospital

    Nanchang, Jiangxi, 330006

  • the First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200086

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang, Liaoning, 110004

  • the Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • the Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • the First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • the Children's Hospital of Shanxi Province

    Taiyuan, Shanxi, 030013

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang Uygur Autonomous Region, 830001

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430022

  • Renmin Hospital of Wuhan University / Hubei General Hospital

    Wuhan, Hubei, 430071

  • Xi'an Children's Hospital

    Xi'an, Shaanxi, 710003

  • Xijing Hospital of Air Force Military Medical University

    Xi'an, Shaanxi, 710032

  • the General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

  • Children's Hospital Affiliated to Zhengzhou University

    Zhengzhou, Henan, 450006

  • the Third Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • the Fifth Affiliated Hospital of Zhengzhou University

    Zhengzhou, Hunan, 450014

  • Affiliated Hospital of Zunyi Medical College

    Zunyi, Guizhou, 563000

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Tumour resection
Keywords
national wide, cross-sectional, retrospective, CNOG-MC001, pediatric, central nervous system tumor
Medical subject headings
Central Nervous System Neoplasms, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tumour resectionProcedure or surgery

    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.

Study groups in NCT04351035
Study groupRoleWhat they receive
Children with CNS tumoursPatients 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.
Receives: Procedure: Tumour resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline information of children with CNS tumours

    Baseline information including gender, age, and institutional geographic data are required for epidemiology analysis.

    Measured: 2 years

  2. 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.

    Measured: 2 year

Secondary outcomes (2)

  1. Overall Survival

    Available overall survival data with post surgery treatments records of enrolled cases is preferred but not mandatory for outcome analysis.

    Measured: 1 year

  2. Progression Free Survival

    Progression free survival data is preferred but not mandatory for outcome analysis.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2020
  2. Study start27 Oct 2018
  3. Primary completion1 Jul 2021
  4. Study completion31 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
4,303 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04351035
Sponsor's protocol ID
CNOG-MC001
Status last verified
Aug 2021
First submitted
16 Apr 2020
Last updated
8 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Tumors, Central Nervous System and Pediatric Brain Tumor, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 38 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline information of children with CNS tumours (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04351035.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.

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