今天是:2019-11-17 星期日

利用卷积神经网络辅助胶囊内镜诊断小肠疾病的前瞻性研究
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注册号:

Registration number:

ChiCTR1900026702 

最近更新日期:

Date of Last Refreshed on:

2019-10-19 

注册时间:

Date of Registration:

2019-10-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

利用卷积神经网络辅助胶囊内镜诊断小肠疾病的前瞻性研究 

Public title:

Prospective Study of Capsule Endoscopy Assisted by Convolutional Neural Network in the Diagnosis of Small Bowel Diseases  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

利用卷积神经网络辅助胶囊内镜诊断小肠疾病的前瞻性研究 

Scientific title:

Prospective Study of Capsule Endoscopy Assisted by Convolutional Neural Network in the Diagnosis of Small Intestinal Diseases  

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:

李岚 

研究负责人:

虞朝辉 

Applicant:

Lan Li 

Study leader:

Chaohui Yu 

申请注册联系人电话:

Applicant telephone:

+86 0571 87236861 

研究负责人电话:

Study leader's telephone:

+86 0571 87236861 

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:

doctorlilan@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zyyyych@zju.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:

浙江省杭州市庆春路79号 

研究负责人通讯地址:

浙江省杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China  

Study leader's address:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital, College of Medicine, Zhejiang 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:

2019-1427 

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:

浙江大学医学院附属第一医院科研伦理审查委员会 

Name of the ethic committee:

Approval Letter of Research Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-17 

伦理委员会联系人:

郑敏 

Contact Name of the ethic committee:

Min Zheng 

伦理委员会联系地址:

浙江省杭州市庆春路79号 

Contact Address of the ethic committee:

79 Qingchun Road, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital, College of Medicine, Zhejiang University 

研究实施负责(组长)单位地址:

杭州市庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, 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):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属第一医院

具体地址:

庆春路79号

Institution
hospital:

The First Affiliated Hospital, College of Medicine, Zhejiang University

Address:

79 Qingchun Road

经费或物资来源:

自筹资金 

Source(s) of funding:

Self-raised funds 

研究疾病:

小肠疾病 

Target disease:

Small Bowel Diseases  

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:

探索性研究/预试验 

Study phase:

研究目的:

研究者拟设计一个卷积神经网络(CNN)系统用以诊断胶囊内镜检查的图像,并进行前瞻性诊断性试验,比较CNN系统和内镜专家对胶囊内镜图像的诊断效率。 

Objectives of Study:

The researchers intend to design a convolutional neural network (CNN) system to diagnose the image of capsule endoscopy, and conduct a prospective diagnostic test to compare the diagnostic efficiency of CNN system and endoscopy experts for capsule endoscopy 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:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1. 至研究者所在医院内镜中心行pillcam胶囊内镜检查的患者所拍摄的胶囊内镜图像; 2. 自愿参加本研究并签署知情同意书者。 

Inclusion criteria

1. Capsule endoscopy images are taken by patients who underwent PillCam capsule endoscopy at the endoscopy center of the researcher's hospital. 2. Patients who volunteer to participate in the study and sign the informed consent form.  

排除标准:

1. 肠道内容物多影响观察的图像; 2. 气泡多影响观察的图像。 

Exclusion criteria:

1. Low-quality images with many intestinal contents. 2. Low-quality images with many bubbles.  

研究实施时间:

Study execute time:

From2020-01-01To 2021-12-31 

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):

大于10年工作经验的胶囊内镜读片医师对胶囊内镜图片的诊断。

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):

Diagnosis of capsule endoscopy images by capsule endoscopy readers with over 10 years of working experience.

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):

卷积神经网络(CNN)系统诊断胶囊内镜检查的图像。

Index test:

Sensitivity, specificity, positive predictive value, negative predictive value, accuracy

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)

pillcam胶囊内镜检查结果发现小肠病变的患者。

例数:

Sample size:

300

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):

Patients with small bowel diseases diagnosed by capsule endoscopy.

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):

pillcam胶囊内镜检查结果发现小肠粘膜未见明显异常的患者。

例数:

Sample size:

300

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

Patients without small bowel diseases diagnosed by capsule endoscopy.

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhe jiang 

City:

 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

省级医疗单位 

Institution
hospital:

The First Affiliated Hospital, College of Medicine, Zhejiang University  

Level of the institution:

Provincial level 

测量指标:

Outcomes:

指标中文名:

敏感性

指标类型:

主要指标 

Outcome:

Sensitivity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

特异性

指标类型:

主要指标 

Outcome:

Specificity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

准确率

指标类型:

主要指标 

Outcome:

Accuracy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

阳性预测值

指标类型:

主要指标 

Outcome:

Positive predictive value

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

阴性预测值

指标类型:

主要指标 

Outcome:

Negative predictive value

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:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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):

不随机

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

Not used

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

纸质版病例记录表

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

CRF

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

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

CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-10-19
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