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基于大数据技术的新型冠状病毒肺炎(COVID-19)辅助诊断决策支持系统的研发
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注册号:

Registration number:

ChiCTR2000030390 

最近更新日期:

Date of Last Refreshed on:

2020-03-01 

注册时间:

Date of Registration:

2020-03-01 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

基于大数据技术的新型冠状病毒肺炎(COVID-19)辅助诊断决策支持系统的研发 

Public title:

Research and Development of Diagnostic Assistance Decision Support System for novel coronavirus pneumonia (COVID-19) Based on Big Data Technology 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于大数据技术的新型冠状病毒肺炎(COVID-19)辅助诊断决策支持系统的研发 

Scientific title:

Research and Development of Diagnostic Assistance Decision Support System for novel coronavirus pneumonia (COVID-19) Based on Big Data Technology 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

刘博罕 

研究负责人:

何昆仑 

Applicant:

Bohan Liu 

Study leader:

Kunlun He 

申请注册联系人电话:

Applicant telephone:

+86 13521343410 

研究负责人电话:

Study leader's telephone:

+86 010 66939107 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

drlbh@outlook.com 

研究负责人电子邮件:

Study leader's E-mail:

hekl301@aliyun.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

北京市海淀区复兴路28号 

研究负责人通讯地址:

北京市海淀区复兴路28号 

Applicant address:

28 Fuxing Road, Haidian District, Beijing, China 

Study leader's address:

28 Fuxing Road, Haidian District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

生物医学工程与转化医学工信部重点实验室 

Applicant's institution:

Key Laboratory of Ministry of Industry and Information Technology of Biomedical Engineering and Translational Medicine 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

S2020-050-01 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

中国人民解放军总医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the General Hospital of the Chinese People's Liberation Army  

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

曹江 

Contact Name of the ethic committee:

Jiang Cao 

伦理委员会联系地址:

北京市海淀区复兴路28号 

Contact Address of the ethic committee:

28 Fuxing Road, Haidian District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

生物医学工程与转化医学工信部重点实验室 

Primary sponsor:

Key Laboratory of Ministry of Industry and Information Technology of Biomedical Engineering and Translational Medicine 

研究实施负责(组长)单位地址:

北京市海淀区复兴路28号 

Primary sponsor's address:

28 Fuxing Road, Haidian District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

生物医学工程与转化医学工信部重点实验室

具体地址:

北京市海淀区复兴路28号

Institution
hospital:

Key Laboratory of Ministry of Industry and Information Technology of Biomedical Engineering and Translational Medicine

Address:

28 Fuxing Road, Haidian District, Beijing, China

经费或物资来源:

研究者自发项目 

Source(s) of funding:

Self-financing 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel coronavirus pneumonia (COVID-19)  

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

1)建立基于大数据技术的辅助诊疗系统; 2)基于胸部CT影像实现全自动、快速、准确地新冠肺炎患者诊断、危险分层与预后预测 

Objectives of Study:

1. To establish Diagnostic Assistance Decision Support System based on big data technology; 2.Automatical, quick and accurate diagnosis, risk stratification and progression prediction in COVID-19 patients based on chest CT images. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1)在医院数据库有明确的临床记录; 2)住院病人有明确的临床诊断和相关实验室检验; 3)CT数据完整,图像质量符合诊断和测量要求; 4)图像存储与传输格式为DICOM文件。 

Inclusion criteria

1. confirmed clinical records in the database of the hospital; 2. inpatients have confirmed clinical diagnosis and relevant laboratory tests; 3. the CT images are complete, the image quality meets the diagnostic and measurement requirements; 4. the format of image storage and transmission is DICOM file.  

排除标准:

排除因屏气配合不良或者操作者因素等导致伪影的病例 

Exclusion criteria:

The cases of artifacts caused by poor breath-holding coordination or operator factors are excluded  

研究实施时间:

Study execute time:

From2020-02-01To 2020-06-01 

征募观察对象时间:

Recruiting time:

From2020-01-01To 2020-04-01 

诊断试验:

Diagnostic Tests:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

新冠病毒核酸检测阳性

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Postive result of SARS-CoV-2 nucleic acid examination

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

辅助诊疗系统

Index test:

Diagnostic Assistance Decision Support System

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

新型冠状病毒肺炎(COVID-19)患者

例数:

Sample size:

3000

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Novel coronavirus pneumonia (COVID-19) patients

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

新型冠状病毒肺炎(COVID-19)疑似病例

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

Suspended Novel coronavirus pneumonia (COVID-19) patients

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

解放军总医院 

单位级别:

三级甲等 

Institution
hospital:

Chinese PLA General Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

解放军第五医学中心 

单位级别:

三级甲等 

Institution
hospital:

The fifth Medical Center of PLA General Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京天坛医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Tiantan Hospital, Capital Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市金银潭医院 

单位级别:

三级甲等 

Institution
hospital:

Wuhan Jinyintan Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市第三医院 

单位级别:

三级甲等 

Institution
hospital:

Wuhan Third Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市红十字会医院 

单位级别:

二级甲等 

Institution
hospital:

Wuhan Red Cross Society Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市江夏区第一人民医院 

单位级别:

二级甲等 

Institution
hospital:

First People's Hospital of Jiangxia District, Wuhan  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市黄陂区人民医院 

单位级别:

三级乙等 

Institution
hospital:

Huangpi District People's Hospital of Wuhan  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

随州市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Suizhou Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

长江大学附属仙桃市第一人民医院 

单位级别:

三级乙等 

Institution
hospital:

Xiantao First People's Hospital Affiliated to Yangtze University  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

秭归县人民医院 

单位级别:

二级甲等 

Institution
hospital:

Zigui County People's Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

温州医科大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Wenzhou Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

温州市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Wenzhou Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

绍兴市人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shaoxing People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

阜阳市第二人民医院 

单位级别:

三级甲等 

Institution
hospital:

Fuyang Second People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

福建 

市(区县):

 

Country:

China 

Province:

Fujian 

City:

 

单位(医院):

莆田学院附属医院 

单位级别:

三级甲等 

Institution
hospital:

Putian College Affiliated Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hunan 

City:

 

单位(医院):

娄底市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Loudi Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

成都市公共卫生临床医疗中心 

单位级别:

三级甲等 

Institution
hospital:

Chengdu Public Health Clinical Medical Center  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

达州市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Dazhou Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

鞍山市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Anshan Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

贵州 

市(区县):

 

Country:

China 

Province:

Guizhou 

City:

 

单位(医院):

贵州省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Guizhou Provincial People's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

电子计算机断层扫描

指标类型:

主要指标 

Outcome:

CT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SEN, SPE, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, AUC of ROC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

N/A

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

未说明

Blinding:

Not stated

是否共享原始数据:

IPD sharing

是Yes

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

因数据公开需要获得患者的知情同意,因此原始数据就不公开了,本文的数据将以论文的形式公开

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Because data disclosure requires informed consent from patients, the original data is not disclosed. The data in this research will be published in the form of papers.

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

数据采集由放射科医生完成。源数据及其文件的管理、采集和录入(记录)由不参与数据分析的专人执行,在执行过程中对需要盲法的研究人员保密。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Data acquisition is performed by radiologists. The management, collection and entry (recording) of source data and its files are performed by technicians who do not participate in data analysis. In the process of implementation,blind researchers are kept confidential.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-01
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