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请于伦理委员会批准后才开始征募参试者,并与我们联系上传伦理批件 肥大细胞促进类风湿性关节炎发病机理研究
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注册号:

Registration number:

ChiCTR2000040167 

最近更新日期:

Date of Last Refreshed on:

2020-11-23 

注册时间:

Date of Registration:

2020-11-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请于伦理委员会批准后才开始征募参试者,并与我们联系上传伦理批件 肥大细胞促进类风湿性关节炎发病机理研究 

Public title:

Research on mast cells promoting the pathogenesis of rheumatoid arthritis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肥大细胞与CD4+T细胞的相互作用在类风湿性关节炎发病机理中的研究 

Scientific title:

Study on the interaction between mast cells and CD4 + T cells in the pathogenesis of rheumatoid arthritis 

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:

雷蕴轩 

研究负责人:

陈广洁 

Applicant:

Yunxuan Lei 

Study leader:

Guangjie Chen 

申请注册联系人电话:

Applicant telephone:

15616123319 

研究负责人电话:

Study leader's telephone:

13917131170 

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:

936241314@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

guangjie_chen@163.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:

上海市重庆南路280号西区五号楼 

研究负责人通讯地址:

上海市重庆南路280号西区五号楼 

Applicant address:

Building 5, 280 South Chongqing Road, Shanghai 

Study leader's address:

Building 5, 280 South Chongqing Road, Shanghai 

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:

上海交通大学医学院 

Applicant's institution:

Shanghai Jiao Tong University School of Medicine 

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:

陈广洁 

Primary sponsor:

Guangjie Chen 

研究实施负责(组长)单位地址:

上海交通大学医学院 

Primary sponsor's address:

Shanghai Jiao Tong University School of Medicine 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院

具体地址:

重庆南路280号

Institution
hospital:

Shanghai Jiao Tong University School of Medicine

Address:

280 South Chongqing Road

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

类风湿性关节炎 

Target disease:

Rheumatoid arthritis 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

本研究的目的是通过分离患病局部关节滑膜的肥大细胞,进行RNA测序分析,了解肥大细胞炎症背景下表型和功能的改变,探索肥大细胞如何与适应性免疫细胞相互作用,为进一步理解肥大细胞促进类风湿性关节炎发展,以及探索靶向肥大细胞治疗提供基础。 

Objectives of Study:

The purpose of this study is to isolate mast cells from the synovium from the diseased joints and perform RNA sequencing analysis to understand the changes in the phenotypes and functions of mast cells.Exploring how mast cells interact with adaptive immune cells provides a basis for further understanding how mast cells promoting the development of rheumatoid arthritis and exploring targeted mast cell therapy. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

(1)年龄≥14岁 (2)符合美国风湿病学会(American College of Rheumatology, ACR)1987 年修正的诊断标准,即确诊类风湿性关节炎或外伤导致需要进行关节置换手术。 

Inclusion criteria

(1) Age ≥14 years old (2) Meet the diagnostic criteria revised by the American College of Rheumatology (ACR) in 1987, that is, a diagnosis of rheumatoid arthritis or trauma causes the need joint replacement surgery. 

排除标准:

(1)年龄<14岁 (2)确诊其他炎症性关节炎如骨关节炎 

Exclusion criteria:

(1) Age <14 years old (2) Other inflammatory arthritis such as osteoarthritis is diagnosed 

研究实施时间:

Study execute time:

From2020-12-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2020-12-01To 2021-06-30 

干预措施:

Interventions:

组别:

类风湿性关节炎组和对照组

样本量:

15

Group:

RA and control

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海市 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市第六人民医院 

单位级别:

三级甲等综合医院 

Institution
hospital:

Shanghai No.6 People Hospital  

Level of the institution:

Tertiary A Hospital  

测量指标:

Outcomes:

指标中文名:

肥大细胞

指标类型:

主要指标 

Outcome:

mast cells

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:

滑膜

组织:

Sample Name:

Synovium

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

血液

组织:

Sample Name:

blood

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:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 14 years
最大 Max age 100 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):

在整个研究中心按照受试者入选的先后顺序,根据预定的随机方案分配入试验组或对照给。随机方案通过查阅随机对照表或采用计算器或计算机产生。

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

In the entire research center, the subjects are assigned to the experimental group or control group according to the predetermined random plan according to the order of selection. The random plan is generated by consulting a random comparison table or using a calculator or computer.

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

ResMan, http://www.medresman.org

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

ResMan, http://www.medresman.org

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

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:

 2020-11-23
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