Today is 2022-05-24

Application of MRI in Breast Cancer Screening
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注册号:

Registration number:

ChiCTR2200055296 

最近更新日期:

Date of Last Refreshed on:

2022-01-05 

注册时间:

Date of Registration:

2022-01-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请与我们联系上传伦理审批文件。 磁共振在乳腺癌筛查中的应用 

Public title:

Application of MRI in Breast Cancer Screening 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

磁共振乳腺癌筛查 

Scientific title:

MRI Screening of Breast Cancer  

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:

许茜 

研究负责人:

许茜 

Applicant:

Qian Xu 

Study leader:

Qian Xu 

申请注册联系人电话:

Applicant telephone:

13933856577 

研究负责人电话:

Study leader's telephone:

13933856577 

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:

xuqianhb@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

xuqianhb@sina.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:

河北省石家庄市长安区健康路12号 

研究负责人通讯地址:

河北省石家庄市长安区健康路12号 

Applicant address:

No.12 of Jiankang Road, Shijiazhuang, Hebei  

Study leader's address:

No.12 of Jiankang Road, Shijiazhuang, Hebei 

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:

河北医科大学第四医院 

Applicant's institution:

The forth hospital of Hebei Medical 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:

2021KS047 

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:

河北医科大学第四医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee, The forth hospital of Hebei Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-11-29 

伦理委员会联系人:

张俊敏 

Contact Name of the ethic committee:

Junmin Zhang 

伦理委员会联系地址:

河北省石家庄市长安区健康路12号 

Contact Address of the ethic committee:

No.12 of Jiankang Road, Shijiazhuang, Hebei  

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:

河北医科大学第四医院 

Primary sponsor:

The fourth hospital of Hebei Medical University 

研究实施负责(组长)单位地址:

河北省石家庄市长安区健康路12号 

Primary sponsor's address:

No 12 Jiankang Road, Shijiazhuang, Hebei, 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):

河北省

市(区县):

石家庄市

Country:

China

Province:

Hebei

City:

Shijiazhuang

单位(医院):

河北医科大学第四医院

具体地址:

河北省石家庄市长安区健康路12号

Institution
hospital:

The fourth hospital of Hebei Medical University

Address:

No. 12 Jiankang Road, Shijiazhuang, Hebei, China

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

乳腺癌 

Target disease:

breast cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

筛查 

Study type:

Screening 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

旨在评估磁共振扫描在乳腺癌筛查中的价值,寻找对乳腺癌敏感性高的序列,优化序列,缩短时间,让磁共振扫描在乳腺癌筛查中发挥更大的优势。 

Objectives of Study:

Designed to evaluate the value of breast MRI in breast cancer screening.Search for sequences with high sensitivity to breast cancer, optimize the sequence, shorten the time, and make MRI scan play a greater advantage in breast cancer screening. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1、40-70岁女性; 2、自愿到提供乳腺磁共振筛查的医疗保健机构进行检查 

Inclusion criteria

1. Women ages 40 to 70 years. 2. Voluntary screening at a health care facility that offers breast MRI screening 

排除标准:

现患乳腺癌(病理确诊),正在接受治疗的 

Exclusion criteria:

Who is suffering from breast cancer (pathologically diagnosed) and is being treated for cancer 

研究实施时间:

Study execute time:

From2022-01-01To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2022-01-01To 2023-12-31 

干预措施:

Interventions:

组别:

筛查

样本量:

100

Group:

Screening

Sample size:

干预措施:

按设定扫描序列扫描

干预措施代码:

Intervention:

Scan the subjects by setting the scan sequence

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北省 

市(区县):

石家庄市 

Country:

China 

Province:

Hebei 

City:

Shijiazhuang 

单位(医院):

河北医科大学第四医院 

单位级别:

三甲级 

Institution
hospital:

The fourth hospital of Hebei Medical University  

Level of the institution:

a Grade Ⅲ Level A hospital 

测量指标:

Outcomes:

指标中文名:

ADC值

指标类型:

主要指标 

Outcome:

ADC values

Type:

Primary indicator 

测量时间点:

扫描完成后

测量方法:

勾画感兴趣区,计算机处理

Measure time point of outcome:

After the scan is complete

Measure method:

Draw ROI,computer processing

指标中文名:

病灶大小

指标类型:

主要指标 

Outcome:

Size of the lesions

Type:

Primary indicator 

测量时间点:

扫描完成后

测量方法:

手动测量

Measure time point of outcome:

After the scan is complete

Measure method:

Measure manually

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

穿刺组织

组织:

乳腺

Sample Name:

Puncture tissue

Tissue:

Breast

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 40 years
最大 Max age 70 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):

技术人员及诊断者分别按随机产生的检查序列号对被检者进行扫描及诊断

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

Technicians and diagnostics scan and diagnose the subjects according to randomly generated inspection serial numbers.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

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):

临床试验公共管理平台 网址:http://www.medresman.org.cn/login.aspx

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

Clinical Trial Management Public Platform Website: http://www.medresman.org.cn/login.aspx

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:

临床试验公共管理平台 网址:http://www.medresman.org.cn/login.aspx

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

Clinical Trial Management Public Platform Website: http://www.medresman.org.cn/login.aspx

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-01-05
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