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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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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 |
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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 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
Medical Ethics Committee of the General Hospital of the Chinese People's Liberation Army |
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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 |
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Contact Name of the ethic committee: |
Jiang Cao |
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伦理委员会联系地址: |
北京市海淀区复兴路28号 |
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Contact Address of the ethic committee: |
28 Fuxing Road, Haidian District, Beijing, China |
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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 |
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Primary sponsor: |
Key Laboratory of Ministry of Industry and Information Technology of Biomedical Engineering and Translational Medicine |
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研究实施负责(组长)单位地址: |
北京市海淀区复兴路28号 |
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Primary sponsor's address: |
28 Fuxing Road, Haidian District, Beijing, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
研究者自发项目 |
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Source(s) of funding: |
Self-financing |
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研究疾病: |
新型冠状病毒肺炎(COVID-19) |
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Target disease: |
Novel coronavirus pneumonia (COVID-19) |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
诊断试验 |
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Study type: |
Diagnostic test |
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研究所处阶段: |
回顾性研究 | ||||||||||||||||||||||
Study phase: |
Retrospective study |
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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 |
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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. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
连续入组 |
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Study design: |
Sequential |
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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。 |
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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. |
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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 |
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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: |
从From2020-02-01至To 2020-06-01 |
征募观察对象时间: Recruiting time: |
从From2020-01-01至To 2020-04-01 |
诊断试验: Diagnostic Tests: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
N/A |
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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. |
数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |