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Artificial intelligence in diagnosis and treatment decision-making of middle ear diseases based on temporal bone CT scans
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注册号:

Registration number:

ChiCTR1900027535 

最近更新日期:

Date of Last Refreshed on:

2019-11-17 

注册时间:

Date of Registration:

2019-11-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

建立基于颞骨CT的中耳疾病智能诊疗系统 

Public title:

Artificial intelligence in diagnosis and treatment decision-making of middle ear diseases based on temporal bone CT scans 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

YUNFENG 

Scientific title:

Artificial intelligence in diagnosis and treatment decision-making of middle ear diseases based on temporal bone CT scans 

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:

王云峰 

研究负责人:

王云峰 

Applicant:

WANG Yunfeng 

Study leader:

WANG Yunfeng 

申请注册联系人电话:

Applicant telephone:

+86 15821994502 

研究负责人电话:

Study leader's telephone:

+86 15821994502 

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:

wyf80612@126.com 

研究负责人电子邮件:

Study leader's E-mail:

wyf80612@126.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:

上海市徐汇区小木桥路538号 

研究负责人通讯地址:

上海市徐汇区小木桥路538号 

Applicant address:

538 Xiao-Mu-Qiao Road, Xuhui District, Shanghai, China 

Study leader's address:

538 Xiao-Mu-Qiao Road, Xuhui District, Shanghai, 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:

复旦大学附属眼耳鼻喉科医院 

Applicant's institution:

Eye & ENT Hospital, Fudan University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

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:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

复旦大学附属眼耳鼻喉科医院 

Primary sponsor:

Eye & ENT Hospital, Fudan University 

研究实施负责(组长)单位地址:

上海市徐汇区汾阳路83号 

Primary sponsor's address:

83 Fenyang Road, Xuhui District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属眼耳鼻喉科医院

具体地址:

上海市徐汇区汾阳路83号

Institution
hospital:

Eye & ENT Hospital, Fudan University

Address:

83 Fenyang Road, Xuhui District, Shanghai

经费或物资来源:

复旦大学附属眼耳鼻喉科医院 

Source(s) of funding:

Eye & ENT Hospital, Fudan University 

研究疾病:

中耳疾病 

Target disease:

Middle ear 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:

本项目拟应用卷积神经网络,建立一个基于颞骨CT影像的中耳疾病人工智能诊疗系统,以实现分泌性中耳炎、慢性化脓性中耳炎、胆脂瘤、颞骨肿瘤性病变的自动化分类诊断,并为临床医生提出下一步诊疗建议。 

Objectives of Study:

The purpose of this study is to build a convolutional neural network based on temporal CT scans. The model is excepted to automatically make diagnosis of secretory otitis media, chronic otitis media, cholesteatoma, and temporal neoplastic lesions, and make recommendations for further diagnosis and treatment of these middle ear 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:

连续入组 

Study design:

Sequential 

纳入标准:

a)自2020年1月至2020年12月在复旦大学附属眼耳鼻喉科医院接受中耳手术的患者; b)术中诊断为分泌性中耳炎、慢性化脓性中耳炎、中耳胆脂瘤或颞骨肿瘤性病变,并由病理结果确证;对于未进行病理检查的患者,以2名具有10年以上工作经验的耳鼻喉科专家的共同意见作为标准。 

Inclusion criteria

1. Patients who undergo middle ear surgeries between January 2020 and December 2020 in Eye & ENT Hospital of Fudan University; 2. Intraoperative diagnosis with secretory otitis media, chronic otitis media, cholesteatoma, and temporal neoplastic lesions are confirmed histologically. For patients without pathological examination, diagnosis is substantiated by two well-experienced otolaryngologists with more than 10-year experience. 

排除标准:

a) 患有心脑血管疾病(包括高血压,心梗史,脑梗史,冠心病史,心功能不全史,各心瓣膜心肌疾病史等),不适合中耳手术的患者; b)无术前CT图像,或图像质量不符合标准; c) 对于合并有胆脂瘤和慢性化脓性中耳炎的患者,优先诊断胆脂瘤。 

Exclusion criteria:

1. Patinets with cardiovascular and cerebrovascular diseases such as hypertension, coronary disease, myocardial infarction, cerebral infarction, cardiac insufficiency, valvular disease, myocardiosis and so on; 2. Patients with no preoperative CT images, or image quality does not meet the standards; 3. For patients with both cholesteatoma and chronic otitis media, diagnosis of cholesteatoma is prioritized. 

研究实施时间:

Study execute time:

From2019-11-17To 2021-12-31 

诊断措施:

Diagnostic measures:

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):

术中诊断为“分泌性中耳炎”、“慢性化脓性中耳炎”、“中耳胆脂瘤”、或肿瘤性病变并由病理结果确证;对于未进行病理检查的患者,以2名具有10年以上工作经验的耳鼻喉科专家的共同意见作为金标准。

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):

Intraoperative diagnosis with secretory otitis media, chronic otitis media, cholesteatoma, and temporal neoplastic lesions are confirmed histologically. For patients without pathological examination, diagnosis is substantiated by two well-experienced otolaryngologists with more than 10-year 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):

人工智能模型

Index test:

artificial intelligence model

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)

分泌性中耳炎、慢性化脓性中耳炎、中耳胆脂瘤或颞骨肿瘤性病变的患者

例数:

Sample size:

400

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 secretory otitis media, chronic otitis media, cholesteatoma, or temporal neoplastic lesions

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):

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:

non

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属眼耳鼻喉科医院 

单位级别:

三级甲等医院 

Institution
hospital:

Eye & ENT Hospital, Fudan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

敏感度

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:

特异度

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:

诊断准确度

指标类型:

主要指标 

Outcome:

Diagnostic accuracy

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:

non

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):

N/A

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

N/A

盲法:

Open label

Blinding:

Open label

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

由需求者通过email索取

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

By email on requirement

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:

 2019-11-17
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