基于CT影像组学及深度学习法对健脾补肾方治疗ARCO2、3期股骨头缺血坏死疗效的早期预测及评估的研究

注册号:

Registration number:

ITMCTR2022000052

最近更新日期:

Date of Last Refreshed on:

2022-07-30

注册时间:

Date of Registration:

2022-06-19

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于CT影像组学及深度学习法对健脾补肾方治疗ARCO2、3期股骨头缺血坏死疗效的早期预测及评估的研究

Public title:

Study of the early prediction and evaluation of the effect of Jianpi Bushen Decoction on Avascular Necrosis of the Femoral Head at ARCO stages 2 and 3 based on CT radiomics and deep learning

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于CT影像组学及深度学习法对健脾补肾方治疗ARCO2、3期股骨头缺血坏死疗效的早期预测及评估的研究

Scientific title:

Study of the early prediction and evaluation of the effect of Jianpi Bushen Decoction on Avascular Necrosis of the Femoral Head at ARCO stages 2 and 3 based on CT radiomics and deep learning

研究课题的正式科学名称简写:

Scientific title acronym:

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:

ChiCTR2200062223 ; ChiMCTR2200006397

申请注册联系人:

杨学东

研究负责人:

杨学东

Applicant:

Xuedong Yang

Study leader:

Xuedong Yang

申请注册联系人电话:

Applicant telephone:

01088001420

研究负责人电话:

Study leader's telephone:

01088001420

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:

yangxuedong1@163.com

研究负责人电子邮件:

Study leader's E-mail:

yangxuedong1@163.com

申请单位网址(自愿提供):

Study leader's 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:

北京市西城区北线阁5号

研究负责人通讯地址:

北京市西城区北线阁5号

Applicant address:

No. 5 Bei Xian Ge Road, Xicheng District, Beijing, China

Study leader's address:

No. 5 Bei Xian Ge Road, Xicheng District, Beijing, 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:

中国中医科学院广安门医院

Applicant's institution:

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2022-089-KY

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

中国中医科学院广安门医院伦理委员会

Name of the ethic committee:

Ethics Committee of Guang'anmen Hospital, Chinese Academy of Chinese Medical Sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2022/4/29 0:00:00

伦理委员会联系人:

乔洁

Contact Name of the ethic committee:

Qiao Jie

伦理委员会联系地址:

北京市西城区北线阁5号中国中医科学院广安门医院老门诊楼203

Contact Address of the ethic committee:

Old Outpatient Building 203,Guang'anmen Hospital,China Academy of Chinese Medical Sciences No. 5 Bei Xian Ge Road, Xicheng District, Beijing, 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:

中国中医科学院广安门医院

Primary sponsor:

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

研究实施负责(组长)单位地址:

北京市西城区北线阁5号 广安门医院

Primary sponsor's address:

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Bei Xian Ge Road, Xicheng District, Beijing, 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):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院广安门医院

具体地址:

北京市西城区北线阁5号

Institution
hospital:

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Address:

No. 5 Bei Xian Ge Road, Xicheng District, Beijing, China

经费或物资来源:

中国中医科学院科技创新工程

Source(s) of funding:

Scientific and technological innovation project of China Academy of Chinese Medical Sciences

研究疾病:

股骨头坏死

研究疾病代码:

Target disease:

Avascular Necrosis of the Femoral Head

Target disease code:

研究类型:

Study type:

预后研究

Prognosis study

研究设计:

Study design:

连续入组

Sequential

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

对股骨头缺血坏死健脾补肾方疗效进行早期预测,建立CT影像组学疗效预测模型;对股骨头缺血坏死健脾补肾方疗效进行早期评估,建立CT影像组学疗效评价模型

Objectives of Study:

To early predict the curative effect of Jianpi Bushen Decoction for avascular necrosis of the femoral head, and to establish a CT radiomics efficacy prediction model; To early evaluate the curative effect of Jianpi Bushen Decoction for avascular necrosis of the femoral head and establish a CT imaging omics curative effect evaluation model.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

就诊于我院骨科,中医辨证符合痰瘀阻络证且进行健脾补肾方治疗的股骨头缺血坏死患者,年龄大于等于18岁。所有患者签署知情同意书,自愿参与本试验。

Inclusion criteria

Patients with avascular necrosis of the femoral head treated with Jianpi Bushen Decoction with the syndrome of phlegm and blood stasis blocking collaterals, and the age is greater than or equal to 18 years old. All patients signed informed consent and voluntarily participated in this trial.

排除标准:

①年龄小于18岁; ②有风湿免疫性疾病,如结缔组织病,强直性脊柱炎等; ③影像上有严重髋关节骨关节病; ④髋关节外伤史; ⑤髋关节手术史或有创检查史、治疗史; ⑥临床资料不完整,未行髋关节Harris评分; ⑦治疗时间短于6个月; ⑧无复查影像资料,或影像资料不完整,图像质量差。

Exclusion criteria:

①Age less than 18 years old; ②Rheumatic immune diseases, such as connective tissue disease, ankylosing spondylitis, etc.; ③Severe hip osteoarthritis on the image; ④History of hip trauma; ⑤History of hip surgery or invasive examination and treatment; ⑥Incomplete clinical data, no Harris score of hip joint; ⑦Treatment time is less than 6 months; ⑧There is nofollow-up image data, or the image data is incomplete and the image quality is poor.

研究实施时间:

Study execute time:

From 2021-10-01

To      2024-10-01

征募观察对象时间:

Recruiting time:

From 2022-08-10

To      2024-04-01

干预措施:

Interventions:

组别:

前瞻性病例组

样本量:

300

Group:

prospective case group

Sample size:

干预措施:

健脾补肾方

干预措施代码:

Intervention:

Jianpi Bushen Decoction

Intervention code:

组别:

回顾性病例组

样本量:

300

Group:

retrospective case group

Sample size:

干预措施:

健脾补肾方

干预措施代码:

Intervention:

Jianpi Bushen Decoction

Intervention code:

样本总量 Total sample size : 600

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Bei jing

City:

单位(医院):

中国中医科学院广安门医院

单位级别:

三甲

Institution/hospital:

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Level of the institution:

tertiary hospital

测量指标:

Outcomes:

指标中文名:

股骨头塌陷深度

指标类型:

主要指标

Outcome:

femoral head collapse depth

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CT影像组学特征-灰度统计量特征

指标类型:

主要指标

Outcome:

CT Radiomics Features-Gray Statistical Features

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CT影像组学特征-形状特征

指标类型:

主要指标

Outcome:

CT radiomic features - shape features

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CT影像组学特征-纹理特征

指标类型:

主要指标

Outcome:

CT radiomic features-texture features

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:

none

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 65
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

由研究人员根据随机数列产生

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

Generated by researchers based on random numbers

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):

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

none

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PACS电子采集管理系统

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

A standard data collection and management system include a CRF and an electronic data capture using PACS

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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