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磁共振用于食管癌术前T分期的临床研究
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注册号:

Registration number:

ChiCTR-DOD-14005308 

最近更新日期:

Date of Last Refreshed on:

2014-10-11 

注册时间:

Date of Registration:

2014-10-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

磁共振用于食管癌术前T分期的临床研究 

Public title:

Magnetic resonance images for preoperative T staging of esophageal cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

磁共振用于食管癌术前T分期的临床研究 

Scientific title:

Magnetic resonance images for preoperative T staging of esophageal 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:

董成来 

研究负责人:

秦建军 

Applicant:

Chenglai Dong 

Study leader:

Jianjun Qin 

申请注册联系人电话:

Applicant telephone:

+86 15138475653 

研究负责人电话:

Study leader's telephone:

+86 13838008630 

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:

1039883687@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

qinjianjun73@aliyun.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:

河南省郑州市金水区东明路127号河南省肿瘤医院胸外科 

研究负责人通讯地址:

河南省郑州市金水区东明路127号河南省肿瘤医院胸外科 

Applicant address:

No.127 Dongming Road, Jinshui District, Zhengzhou 

Study leader's address:

No.127 Dongming Road, Jinshui District, Zhengzhou 

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:

河南省肿瘤医院 

Applicant's institution:

Henan Cancer Hospital 

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:

河南省肿瘤医院 

Primary sponsor:

Henan Cancer Hospital 

研究实施负责(组长)单位地址:

河南省郑州市金水区东明路127号 

Primary sponsor's address:

No.127 Dongming Road, Jinshui District, Zhengzhou 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

河南

市(区县):

Country:

China

Province:

Henan

City:

单位(医院):

河南省肿瘤医院

具体地址:

河南省郑州市金水区东明路127号

Institution
hospital:

Henan Cancer Hospital

Address:

No.127 Dongming Road, Jinshui District, Zhengzhou

经费或物资来源:

自筹 

Source(s) of funding:

self-funding 

研究疾病:

食管癌 

Target disease:

Esophageal Cancer 

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:

其它 

Study phase:

N/A 

研究目的:

评价MRI用于食管癌术前T分期的价值 

Objectives of Study:

To evaluate the diagnostic accuracy of magnetic resonance images in the preoperative T staging of esophageal cancer 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

诊断试验诊断准确性 

Study design:

Diagnostic test for accuracy 

纳入标准:

1.术前经胃镜活检证实为食管癌并且均行MRI检查 2.术后病理证实 

Inclusion criteria

1.Patients have biopsy proved esophageal cancer and underwent MRI before surgery; 2.pathological confirmation after radical resection of oesophageal cancer. 

排除标准:

不能满足任一入组条件的患者 

Exclusion criteria:

Cases which did not satisfy with any item in inclusion criteria 

研究实施时间:

Study execute time:

From2014-10-02To 2014-10-02 

征募观察对象时间:

Recruiting time:

From2014-10-02To 2015-10-02 

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):

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):

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):

Index test:

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)

例数:

Sample size:

0

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):

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:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

河南省肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

Henan Cancer Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

准确性

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:

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:

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:

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 30 years
最大 Max age 80 years

性别:

Gender:

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:

Blinding:

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:

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):

河南省肿瘤医院

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

Henan Cancer Hospital

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:

河南省肿瘤医院

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

Henan Cancer Hospital

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-10-02
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