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细胞外组蛋白在全身型幼年特发性关节炎中的临床意义及其机制研究
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注册号:

Registration number:

ChiCTR-OOC-15006228 

最近更新日期:

Date of Last Refreshed on:

2015-04-13 

注册时间:

Date of Registration:

2015-04-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

细胞外组蛋白在全身型幼年特发性关节炎中的临床意义及其机制研究 

Public title:

Clinical and mechanism research of extracellular histone in systemic-onset juvenile idiopathic arthritis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

细胞外组蛋白在全身型幼年特发性关节炎中的临床意义及其机制研究 

Scientific title:

Clinical and mechanism research of extracellular histone in systemic-onset juvenile idiopathic 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:

胡筱 

研究负责人:

金燕樑 

Applicant:

Xiao Hu 

Study leader:

Yanliang Jin 

申请注册联系人电话:

Applicant telephone:

+86 18817821840 

研究负责人电话:

Study leader's telephone:

+86 13501622815 

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:

huxiao09@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

jinyanliang2000@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:

上海市东方路1678号上海儿童医学中心 

研究负责人通讯地址:

上海市东方路1678号上海儿童医学中心 

Applicant address:

1678 DongFang Road, Shanghai 

Study leader's address:

1678 DongFang 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:

上海儿童医学中心 

Applicant's institution:

Shanghai Children's Medical Center 

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:

SCMCIRB-K2014071 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

上海交通大学医学院附属上海儿童医学中心伦理委员会 

Name of the ethic committee:

IRB of Shanghai Children's Medical Center Affiliated Shanghai Jiao Tong University School of Meicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-12-10 

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:

上海儿童医学中心 

Primary sponsor:

Shanghai Children's Medical Center 

研究实施负责(组长)单位地址:

上海市东方路1678号上海儿童医学中心 

Primary sponsor's address:

1678 DongFang Road, Shanghai 

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(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海儿童医学中心

具体地址:

上海市东方路1678号

Institution
hospital:

Shanghai Children's Medical Center

Address:

1678 DongFang Road, Shanghai

经费或物资来源:

自筹经费 

Source(s) of funding:

Self-financing 

研究疾病:

全身型幼年性特发性关节炎 

Target disease:

systemic-onset juvenile idiopathic arthritis 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

全身型幼年特发性关节炎(systemic-onset juvenile idiopathic arthritis,SoJIA)是一种全身炎症性疾病,属于幼年特发性关节炎(juvenile idiopathic arthritis,JIA)的一种亚型。至今病因仍不清楚,其病情常呈慢性反复发作,治疗困难。本研究探讨SoJIA患儿血清中组蛋白水平与疾病活动性之间的相关性、血清组蛋白在SoJIA中的临床意义及机制研究,为难治性SoJIA的治疗提供理论依据。 

Objectives of Study:

Systemic juvenile idiopathic arthritis (SoJIA) is a systemic inflammatory disease classified as a subtype of JIA.The pathogenesis of this disease is still not clear. And this chronic disease relapse often and difficult to treat. This study dicuss serum histone levels of SoJIA patients, and The clinical value and mechanism of serum histones in SoJIA, provide theoretical basis for the treatment of refractory SoJIA. 

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:

符合国际风湿学协会制定的SoJIA诊断标准 

Inclusion criteria

Children to be diagnosed with SoJIA, according to the criteria of the International League of Rheumatology Alliance. 

排除标准:

感染、肿瘤等疾病 

Exclusion criteria:

Infection, tumor 

研究实施时间:

Study execute time:

From2015-04-01To 2016-10-01 

干预措施:

Interventions:

组别:

活动组和缓解组

样本量:

30

Group:

disease active group,disease remission group

Sample size:

干预措施:

将肝素加入体外培养的中性粒细胞中

干预措施代码:

Intervention:

add heparin into neutrophils in vitro

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(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海儿童医学中心 

单位级别:

三甲医院 

Institution
hospital:

Shanghai Children's Medical Cente  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

产生NETs的中性粒细胞百分比

指标类型:

主要指标 

Outcome:

Percentage of neutrophils which release NETs

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:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 3 years
最大 Max age 16 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:

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-04-09
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