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Study on treatment strategy of COVID-19 by Radiologic imaging combined with pathology diagnosis with AI
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注册号:

Registration number:

ChiCTR2100047688 

最近更新日期:

Date of Last Refreshed on:

2021-06-21 

注册时间:

Date of Registration:

2021-06-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型冠状病毒肺炎(COVID-19)AI影像-病理诊疗策略研究 

Public title:

Study on treatment strategy of COVID-19 by Radiologic imaging combined with pathology diagnosis with AI 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型冠状病毒肺炎AI影像-病理诊疗策略研究 

Scientific title:

Study on treatment strategy of COVID-19 by Radiologic imaging combined with pathology diagnosis with AI 

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:

何志承 

研究负责人:

卞修武 

Applicant:

Zhicheng He 

Study leader:

Xiuwu Bian 

申请注册联系人电话:

Applicant telephone:

+86 15823412045 

研究负责人电话:

Study leader's telephone:

+86 13708373857 

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:

hzcswhp@163.com 

研究负责人电子邮件:

Study leader's E-mail:

bianxiuwuoffice@163.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:

重庆市沙坪坝区高滩岩正街30号 

研究负责人通讯地址:

重庆市沙坪坝区高滩岩正街30号,陆军军医大学西南医院 

Applicant address:

30 Gaotanyan Main Street, Shapingba District, Chongqing, China 

Study leader's address:

30 Gaotanyan Main Street, Shapingba District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

400038 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

陆军军医大学西南医院 

Applicant's institution:

Southwest Hospital of Army Medical University 

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:

KY2020298 

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:

中国人民解放军陆军军医大学第一附属医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Army Medical University,PLA 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-12-18 

伦理委员会联系人:

蒋璐灿 

Contact Name of the ethic committee:

Luchan Jiang 

伦理委员会联系地址:

重庆市沙坪坝区高滩岩正街29号 

Contact Address of the ethic committee:

29 Gaotanyan Main Street, Shapingba District, Chongqing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 023-68754814 

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:

陆军军医大学西南医院 

Primary sponsor:

Southwest Hospital of Army Medical University 

研究实施负责(组长)单位地址:

重庆市沙坪坝区高滩岩正街30号陆军军医大学西南医院 

Primary sponsor's address:

30 Gaotanyan Main Street, Shapingba District, Chongqing, 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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

陆军军医大学西南医院

具体地址:

重庆市沙坪坝区高滩岩正街30号,陆军军医大学西南医院

Institution
hospital:

Southwest Hospital of Army Medical University

Address:

30 Gaotanyan Main Street, Shapingba District

国家:

中国

省(直辖市):

广东

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

南方医科大学南方医院

具体地址:

广州市广州大道北1838号

Institution
hospital:

Nan Fang Hospital, Southern Medical University

Address:

1838 Guangzhou Avenue North, Guangzhou

国家:

中国

省(直辖市):

安徽

市(区县):

Country:

China

Province:

Anhui

City:

单位(医院):

中国科技大学第一附属医院

具体地址:

合肥市庐阳区庐江路17号

Institution
hospital:

The First Affliated Hospital of University of Science and Technology of China

Address:

17 Lujiang Road, Luyang District, Hefei

国家:

中国

省(直辖市):

湖北

市(区县):

Country:

China

Province:

Hubei

City:

单位(医院):

华中科技大学同济医学院附属协和医院

具体地址:

湖北省武汉市江汉区解放大道1277号

Institution
hospital:

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address:

277 Jiefang Avenue, Jianghan District, Wuhan City, Hubei Province

经费或物资来源:

重庆新型冠状病毒感染的特征规律研究 

Source(s) of funding:

Study on the characteristics of COVID-19 in Chongqing 

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:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

通过对新型冠状病毒死亡患者尸体解剖后的组织标本HE染色和影像学资料进行对比,并使用人工智能算法对相关资料进行深度学习,获得更为准确的病理-影像联合诊断方案,提高重大传染病诊疗过程中的精准性。 

Objectives of Study:

By comparing the HE staining and Radiography imaging data of the COVID-19 patients after autopsy, and the artificial intelligence algorithm was used to deep learning the relevant data, and a more accurate treatment strategy of COVID-19 by Radiologic imaging combined with pathology diagnosis with AI was obtained to improve accuracy in the diagnosis and treatment of major infectious diseases. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例研究 

Study design:

Case study 

纳入标准:

临床已明确诊断为新型冠状病毒肺炎的死亡患者 

Inclusion criteria

Clinically diagnosed as COVID-19 died patients 

排除标准:

诊断不明确的病例 

Exclusion criteria:

Cases with unclear diagnosis 

研究实施时间:

Study execute time:

From2021-09-01To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2021-08-01To 2021-12-31 

干预措施:

Interventions:

组别:

3

样本量:

26

Group:

3

Sample size:

干预措施:

干预措施代码:

Intervention:

no

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

陆军军医大学西南医院 

单位级别:

三甲 

Institution
hospital:

Southwest Hospital of Army Medical University  

Level of the institution:

3 armour hospital 

测量指标:

Outcomes:

指标中文名:

浆液

指标类型:

主要指标 

Outcome:

serous

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

粘液

指标类型:

主要指标 

Outcome:

mucus

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

纤维素

指标类型:

主要指标 

Outcome:

cellulose

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出血

指标类型:

主要指标 

Outcome:

hemorrhage

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:

标本中文名:

肺组织

组织:

Sample Name:

lung tissue

Tissue:

lung

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 53 years
最大 Max age 89 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):

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

no

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

临床试验公共管理平台 (www.medresman.org)

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

Public management platform for clinical trials(www.medresman.org)

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:

电子采集和管理系统

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

Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2021-06-21
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