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应用基于彩色多普勒超声的深度学习方法对子宫肿瘤分类及早期诊断的研究
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注册号:

Registration number:

ChiCTR1800017554 

最近更新日期:

Date of Last Refreshed on:

2019-03-24 

注册时间:

Date of Registration:

2018-08-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

应用基于彩色多普勒超声的深度学习方法对子宫肿瘤分类及早期诊断的研究 

Public title:

Study for the classification of uterine tumor using ultrasonography and deep learning 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

应用基于彩色多普勒超声的深度学习方法对子宫肿瘤分类及早期诊断的研究 

Scientific title:

Study for the classification of uterine tumor using ultrasonography and deep learning 

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:

汪雯雯 

研究负责人:

王世宣 

Applicant:

Wang Wenwen 

Study leader:

Wang Shixuan 

申请注册联系人电话:

Applicant telephone:

+86 15927167698 

研究负责人电话:

Study leader's telephone:

+86 13995553319 

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:

petrawang@163.com 

研究负责人电子邮件:

Study leader's E-mail:

shixuanwang@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:

中国湖北武汉市解放大道1095号 

研究负责人通讯地址:

中国湖北武汉市解放大道1095号 

Applicant address:

1095 Jiefang Road, Wuhan, Hubei, China 

Study leader's address:

1095 Jiefang Road, Wuhan, Hubei, 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:

华中科技大学 

Applicant's institution:

Huazhong University of Science and Technology 

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:

TJ-IRB20180618 

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:

华中科技大学同济医学院附属同济医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Tongji Hospital affiliated with Huazhong University of Science and Technology 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-07-05 

伦理委员会联系人:

常慕君 

Contact Name of the ethic committee:

CHANG MUJUN 

伦理委员会联系地址:

武汉市解放大道1095号 

Contact Address of the ethic committee:

1095 Jiefang Road, Wuhan, Hubei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 027 83663625 

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:

华中科技大学附属同济医院 

Primary sponsor:

Tongji Hospital of Huazhong University of Science and Technology 

研究实施负责(组长)单位地址:

武汉市解放大道1095号 

Primary sponsor's address:

1095 Jiefang Road, Wuhan, Hubei, 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):

湖北

市(区县):

武汉

Country:

China

Province:

HuBei

City:

Wuhan

单位(医院):

华中科技大学附属同济医院

具体地址:

武汉市解放大道1095号

Institution
hospital:

Tongji Hospital of Huazhong University of Science and Technology

Address:

1095 Jiefang Road, Wuhan, Hubei, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-raising 

研究疾病:

子宫肿瘤 

Target disease:

Uterine Tumor 

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:

通过开发具备人工智能的计算机辅助诊断系统,综合子宫肿瘤的超声图像信息进行智能诊断,弥补人工诊断的“主观性”的缺陷,提高诊断效率的同时提升精准且无创性诊断水平。最终实现子宫肿瘤的精确分类,从而指导良性子宫肿瘤患者进行相关治疗方案的选择,同时提高恶性子宫肿瘤的早期诊断率。 

Objectives of Study:

The development of artificial intelligence computer-aided diagnosis system could make up the "subjectivity" defect of artificial diagnosis with ultrasonic images, improve the diagnosis efficiency and elevate the accurate and noninvasive diagnostic level. Finally, the accurate classification of uterine tumors is carried out to guide patients with benign uterine tumors to choose the relevant treatment, and to improve the early diagnosis rate of malignant uterine tumors.  

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.临床及病理诊断为子宫内膜息肉、子宫内膜增生、子宫内膜癌、子宫平滑肌瘤、子宫腺肌病(局限型)以及子宫肉瘤; 2.具备图像质量良好的病灶彩色多普勒超声声像图. 

Inclusion criteria

1. Clinical and pathological diagnosis of endometrial polyps, endometrial hyperplasia, endometrial carcinoma, uterine leiomyoma, adenomyosis (limited type) and uterine sarcoma; 2. Color Doppler ultrasound imaging should have good image quality. 

排除标准:

图像质量不好的病灶彩色多普勒超声声像图 

Exclusion criteria:

Poor color doppler ultrasound images 

研究实施时间:

Study execute time:

From2018-08-01To 2021-07-31 

征募观察对象时间:

Recruiting time:

From2018-08-01To 2021-07-31 

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):

彩色多普勒超声检查或盆腔磁共振检查

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):

color doppler ultrasound or MRI

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):

计算机辅助诊断

Index test:

computer assistant diagnosis

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)

子宫内膜息肉、子宫内膜增生、子宫内膜癌、子宫平滑肌瘤、子宫腺肌病(局限型)以及子宫肉瘤

例数:

Sample size:

1000

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):

endometrial polyps, endometrial hyperplasia, endometrial carcinoma, uterine leiomyoma, adenomyosis (limited type) and uterine sarcoma

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:

1000

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

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学附属同济医院 

单位级别:

三级甲等 

Institution
hospital:

Tongji hospital of Huazhong University of Science and Techonology  

Level of the institution:

Tertiary A hospital 

国家:

日本 

省(直辖市):

福岛 

市(区县):

会津若松 

Country:

Japan 

Province:

Fukushima 

City:

Aizu-Wakamatsu 

单位(医院):

会津大学 

单位级别:

公立大学 

Institution
hospital:

University of Aizu  

Level of the institution:

Public university 

测量指标:

Outcomes:

指标中文名:

SPE, SEN, ACC, ROC

指标类型:

主要指标 

Outcome:

SPE, SEN, ACC, ROC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

诊断准确率

指标类型:

主要指标 

Outcome:

Accuracy Rate

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:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

非随机方法

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

Non-random method

盲法:

Not stated

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

不予公开原始数据

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

No disclosure of raw data

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:

病历记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-08-03
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