今天是:2020-08-11 星期二

利用单细胞测序法研究幼年型皮肌炎的发病机制
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注册号:

Registration number:

ChiCTR2000034590 

最近更新日期:

Date of Last Refreshed on:

2020-07-11 

注册时间:

Date of Registration:

2020-07-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

利用单细胞测序法研究幼年型皮肌炎的发病机制 

Public title:

Explore the Pathogenesis of Juvenile Dermatomyositis with Single Cell Sequencing  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

利用单细胞测序法研究幼年型皮肌炎的发病机制 

Scientific title:

Explore the Pathogenesis of Juvenile Dermatomyositis with Single Cell Sequencing  

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:

陈香元 

Applicant:

Chen Xiangyuan 

Study leader:

Chen Xiangyuan 

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 18198915321 

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:

very88happy@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号过敏免疫风湿科 

研究负责人通讯地址:

广州市越秀区人民中路318号过敏免疫风湿科 

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:

Department of Allergy Immunology and Rheumatology, 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32401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's Medical Center 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-07-03 

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号广州市妇女儿童医疗中心伦理委员会办公室 

Contact Address of the ethic committee:

Ethics Committee of Guangzhou Women and Children's Medical Center, 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:

广州市天河区金穗路9号 

Primary sponsor's address:

Guangzhou Women and Children's Medical Center,9 Jinsui Road, Tianhe 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:

广州市天河区金穗路9号

Institution
hospital:

Guangzhou Women and Children's Medical Center

Address:

9 Jinsui Road, Tianhe District, Guangzhou

经费或物资来源:

儿童内科部课题基金 

Source(s) of funding:

Research Fund of the Department of Peadiatric Internal Medicine 

研究疾病:

幼年型皮肌炎 

Target disease:

Juvenile Dermatomyositis 

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:

其它 

Study phase:

N/A 

研究目的:

幼年型皮肌炎的发病机制目前尚未明确,本研究利用单细胞测序法进一步研究幼年型皮肌炎的发病机制。 

Objectives of Study:

The pathogenesis of juvenile dermatomyositis is still not clear. In this study, single cell sequencing was used to further study the pathogenesis of juvenile dermatomyositis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例研究 

Study design:

Case study 

纳入标准:

按照幼年型皮肌炎的诊断指南,确诊为幼年型皮肌炎的患儿。 

Inclusion criteria

According to the diagnostic guidelines for juvenile dermatomyositis, children diagnosed with juvenile dermatomyositis. 

排除标准:

幼年型皮肌炎合并急性感染,重型生命体征不稳定者。 

Exclusion criteria:

Juvenile dermatomyositis complicated with acute infection, severe vital signs was unstable. 

研究实施时间:

Study execute time:

From2020-07-09To 2023-12-31 

征募观察对象时间:

Recruiting time:

From2020-07-09To 2023-07-31 

干预措施:

Interventions:

组别:

疾病组

样本量:

2

Group:

Cases

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

routine therapy

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 

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:

单个细胞基因表达分析

指标类型:

主要指标 

Outcome:

Single cell gene expression analysis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

细胞标记基因鉴定

指标类型:

主要指标 

Outcome:

Cell marker gene identification

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

差异表达基因验证分析

指标类型:

主要指标 

Outcome:

Differential expression gene verification analysis

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:

外周血管

Sample Name:

Peripheral blood

Tissue:

Peripheral vessels

人体标本去向

使用后销毁 

说明

新鲜样品

Fate of sample:

Destruction after use 

Note:

Fresh samples

标本中文名:

受累大腿肌肉

组织:

Sample Name:

Involved thigh muscles

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 2 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):

N/A

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):

Calculated Results after
the Study Completed(upload file):

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):

原始数据传输,表格,内容

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

Raw data transfer, table, content

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:

有/Yes

注册人:

Name of Registration:

 2020-07-11
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