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Research on the application value of non-invasive rapid tumor early screening based on imaging artificial intelligence
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注册号:

Registration number:

ChiCTR2100054330 

最近更新日期:

Date of Last Refreshed on:

2021-12-28 

注册时间:

Date of Registration:

2021-12-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于影像人工智能对无创快速肿瘤早筛的应用价值研究 

Public title:

Research on the application value of non-invasive rapid tumor early screening based on imaging artificial intelligence  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于影像人工智能对无创快速肿瘤早筛的应用价值研究 

Scientific title:

Research on the application value of non-invasive rapid tumor early screening based on imaging artificial intelligence  

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:

黄慧 

研究负责人:

王伟 

Applicant:

Hui huang 

Study leader:

Wei wang 

申请注册联系人电话:

Applicant telephone:

020-87765183 

研究负责人电话:

Study leader's telephone:

020-87765183 

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:

huangh233@mail.sysu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

chenlda@mail.sysu.edu.cn 

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:

广州市中山大学附属第一医院 

研究负责人通讯地址:

广州市中山大学附属第一医院 

Applicant address:

The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 

Study leader's address:

The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 

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:

中山大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 

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:

伦审[2021]560号 

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:

中山大学附属第一医院临床科研和实验动物伦理委员会 

Name of the ethic committee:

IEC for clinical research and animal trails of the First Affiliated Hospital of Sun Yat-Sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-09-01 

伦理委员会联系人:

颜楚荣 

Contact Name of the ethic committee:

Churong Yan 

伦理委员会联系地址:

广州市中山大学附属第一医院 

Contact Address of the ethic committee:

The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 

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:

中山大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 

研究实施负责(组长)单位地址:

广州市中山大学附属第一医院 

Primary sponsor's address:

The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

广州市中山大学附属第一医院

具体地址:

中山二路58号

Institution
hospital:

The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou

Address:

58 Zhongshan Second Road

经费或物资来源:

国家自然科学基金 面上项目(NO:82171960) 

Source(s) of funding:

National Nature Science Foundation of China 

研究疾病:

肝癌、乳腺癌和甲状腺癌 

Target disease:

Cancer of the liver, breast and thyroid 

研究疾病代码:

 

Target disease code:

 

研究类型:

筛查 

Study type:

Screening 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本研究旨在利用影像人工智能对肿瘤早筛进行无创快速检出,建立基于仿生网络检测肿瘤的临床决策模型。 

Objectives of Study:

This study aims to use image artificial intelligence for noninvasive and rapid detection of tumor early screening and establish a clinical decision model for tumor detection based on bionic network.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

a.年龄>18岁;b.具备肝脏、甲状腺、乳腺占位影像、检验、病理资料;c.患者签署超声造影书面知情同意书 

Inclusion criteria

A. Age >18 years; B. Have imaging, examination and pathological data of liver, thyroid and breast space; C. Patients signed written informed consent for contrast-enhanced ultrasound  

排除标准:

a.病理或临床诊断尚不明确;b.影像学资料缺失或不完整; 

Exclusion criteria:

A. The pathological or clinical diagnosis is not clear; B. Imaging data missing or incomplete;  

研究实施时间:

Study execute time:

From2022-01-01To 2032-12-31 

征募观察对象时间:

Recruiting time:

From2022-01-01To 2032-12-31 

干预措施:

Interventions:

组别:

观察组

样本量:

1000

Group:

observation group

Sample size:

干预措施:

影像检查

干预措施代码:

Intervention:

image examination

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

中山大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou  

Level of the institution:

Third rate 

测量指标:

Outcomes:

指标中文名:

影像组学

指标类型:

主要指标 

Outcome:

radiomics

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:

影像图像

组织:

Sample Name:

images

Tissue:

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:

尚未开始

Not yet 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):

连续纳入

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

enroll consecutive patients

盲法:

Blinding:

是否共享原始数据:

IPD sharing

No

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):

研究结束后经负责单位同意后邮件共享

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

After the study, the email will be shared with the consent of the responsible unit

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:

病例记录表和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:

Case Record Form and Electronic Data Capture

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-12-14
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