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类风湿关节炎患者血清DKK-1水平与骨破坏、炎症相关分析
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注册号:

Registration number:

ChiCTR-CCC-10001054 

最近更新日期:

Date of Last Refreshed on:

2015-07-03 

注册时间:

Date of Registration:

2010-08-25 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

类风湿关节炎患者血清DKK-1水平与骨破坏、炎症相关分析 

Public title:

Circulating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid Arthritis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

类风湿关节炎患者血清DKK-1水平与骨破坏、炎症相关分析 

Scientific title:

Circulating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid Arthritis 

研究课题代号(代码):

Study subject ID:

国家自然科学基金(No.30972710),国际基础研究发展计划(Grant No. 2010CB529100) 

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:

王世瑶 

研究负责人:

栗占国 

Applicant:

wangshiyao 

Study leader:

lizhanguo 

申请注册联系人电话:

Applicant telephone:

+86 10 88324172 

研究负责人电话:

Study leader's telephone:

+86 10 88324172 

申请注册联系人传真 :

Applicant Fax:

+86 10 88378021 

研究负责人传真:

Study leader's fax:

+86 10 88378021 

申请注册联系人电子邮件:

Applicant E-mail:

wangshiyao78@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

zgli98@yahoo.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:

北京大学人民医院风湿免疫科,北京西直门南大街11号 

研究负责人通讯地址:

北京大学人民医院风湿免疫科,北京西直门南大街11号 

Applicant address:

Department of Rheumatology and Immunology, Clinical Immunology Center, Beijing University People's Hospital; 11 Xizhimen South Street, Beijing 

Study leader's address:

Department of Rheumatology and Immunology, Clinical Immunology Center, Beijing University People's Hospital; 11 Xizhimen South Street, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100044 

研究负责人邮政编码:

Study leader's postcode:

100044 

申请人所在单位:

北京大学人民医院 

Applicant's institution:

Beijing University People's Hospital 

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:

fwa00001384 

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:

北京大学人民医院伦理委员会 

Name of the ethic committee:

Research Ethics Committee at the Beijing University People’s Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2008-08-01 

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:

北京大学人民医院 

Primary sponsor:

National Sciences Foundation of China 

研究实施负责(组长)单位地址:

北京西直门南大街11号 

Primary sponsor's address:

11 Nanda Streat, Haidian shuangqing road, Beijing ,China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

国家自然科学基金(No.30972710),国际基础研究发展计划(Grant No. 2010CB529100) 

Source(s) of funding:

National Basic Research Program of China (Grant No. 2010CB529100) and the National Sciences Foundation of China (Grant No.30972710) 

研究疾病:

类风湿\关节炎 

Target disease:

ra 

研究疾病代码:

q01 

Target disease code:

q01 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

研究DKK-1在RA病理损伤中的作用 

Objectives of Study:

To explore the potential role of Dickkopf-1 (DKK-1) in rheumatoid arthritis (RA) and to evaluate the effect of tumor necrosis factor-alpha (TNF-alpha) inhibitor (Infliximab) and Interleukin-1 receptor antagonist (IL-1 Ra) (Anakinra) on DKK-1 secretion in RA patients. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

活动期类风湿关节炎 

Inclusion criteria

Active rheumatoid arthritis 

排除标准:

严重的全身系统疾病 

Exclusion criteria:

with severe systemic disease 

研究实施时间:

Study execute time:

From2008-01-01To 2009-01-31 

征募观察对象时间:

Recruiting time:

From2008-01-01To 2009-01-31 

干预措施:

Interventions:

组别:

1

样本量:

39

Group:

1

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

组别:

2

样本量:

39

Group:

2

Sample size:

干预措施:

Infliximab

干预措施代码:

Intervention:

Infliximab

Intervention code:

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:

Beijing 

City:

 

单位(医院):

北京大学人民医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing University People’s Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

erythrocyte sedimentation rate

指标类型:

主要指标 

Outcome:

erythrocyte sedimentation rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C-reactive protein

指标类型:

主要指标 

Outcome:

C-reactive protein

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 28 years
最大 Max age 58 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):

NA

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

NA

盲法:

RA 患者 盲法 随机序列表

Blinding:

RA patients: blinding

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否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):

北京大学人民医院

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

Beijing University People’s 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:

北京大学人民医院

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

Beijing University People’s Hospital

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2010-08-25
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