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真实世界幼年特发性关节炎PRINTO新分类标准验证
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注册号:

Registration number:

ChiCTR2000034643 

最近更新日期:

Date of Last Refreshed on:

2020-07-13 

注册时间:

Date of Registration:

2020-07-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

真实世界幼年特发性关节炎PRINTO新分类标准验证 

Public title:

Real-world verification of PRINTO new classification standard of juvenile idiopathic arthritis  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

真实世界幼年特发性关节炎PRINTO新分类标准验证 

Scientific title:

Real-world verification of PRINTO new classification standard of 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:

陈香元 

研究负责人:

曾华松 

Applicant:

Chen Xiangyuan 

Study leader:

Zeng Huasong 

申请注册联系人电话:

Applicant telephone:

+86 18198915321 

研究负责人电话:

Study leader's telephone:

+86 18902268736 

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:

very88happy@163.com 

研究负责人电子邮件:

Study leader's E-mail:

huasongxuqing@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:

广州市越秀区人民中路318号 

研究负责人通讯地址:

广州市越秀区人民中路318号 

Applicant address:

318 Renmin Middle Road, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

318 Renmin Middle Road, Yuexiu District, Guangzhou, Guangdong, China 

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:

广州市妇女儿童医疗中心 

Applicant's institution:

Guangzhou Women and 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:

[2020]第31601号 

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:

广州市妇女儿童医疗中心伦理委员会 

Name of the ethic committee:

Ethics Committee of Guangzhou Women and Children Medical Center 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-07-08 

伦理委员会联系人:

李庆丰 

Contact Name of the ethic committee:

Li Qingfeng 

伦理委员会联系地址:

广州市天河区金穗路9号 

Contact Address of the ethic committee:

9 Jinsui Road, Tianhe District, Guangzhou, Guangdong, China  

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:

广州市妇女儿童医疗中心 

Primary sponsor:

Guangzhou Women and Children's Medical Center 

研究实施负责(组长)单位地址:

广州市越秀区人民中路318号 

Primary sponsor's address:

318 Renmin Middle Road, Yuexiu District, Guangzhou, Guangdong, 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州市妇女儿童医疗中心

具体地址:

广州市越秀区人民中路318号

Institution
hospital:

Guangzhou Women and Children's Medical Center

Address:

318 Renmin Middle Road, Yuexiu District, Guangzhou

经费或物资来源:

广州市妇女儿童医疗中心内科部 

Source(s) of funding:

Department of Internal Medicine, Guangzhou Women and Children's Medical Center 

研究疾病:

幼年特发性关节炎 

Target disease:

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:

PRINTO幼年特发性关节炎新标准在中国广东地区的分类验证 

Objectives of Study:

Validation of PRINTO New Standard for Juvenile Idiopathic Arthritis in Guangdong, China 

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:

所有符合1995年国际风湿病学协会联盟的幼年特发性关节炎的诊断标准的患儿 

Inclusion criteria

all children who met the diagnostic criteria for juvenile idiopathic arthritis of the International League of Associations for Rheumatology in 1995 

排除标准:

No 

Exclusion criteria:

No 

研究实施时间:

Study execute time:

From2020-07-08To 2025-12-31 

征募观察对象时间:

Recruiting time:

From2020-07-12To 2025-12-31 

干预措施:

Interventions:

组别:

疾病组

样本量:

100

Group:

Case series

Sample size:

干预措施:

观察入组病人的临床资料

干预措施代码:

Intervention:

Observe the clinical data of the enrolled patients

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou city 

单位(医院):

广州市妇女儿童医疗中心 

单位级别:

三甲医院 

Institution
hospital:

Guangzhou Women and Children's Medical Center  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

体重

指标类型:

主要指标 

Outcome:

weight

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身高

指标类型:

主要指标 

Outcome:

high

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:

外周血

组织:

Sample Name:

Peripheral 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 1 years
最大 Max age 18 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):

确诊病人连续入组

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

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):

原始表格数据上传

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

upload the original form data

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,电子采集和管理系统

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

Case Record Form,Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-07-12
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