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我国儿童炎症性肠病的随访研究
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注册号:

Registration number:

ChiCTR1800015160 

最近更新日期:

Date of Last Refreshed on:

2018-03-11 

注册时间:

Date of Registration:

2018-03-11 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

我国儿童炎症性肠病的随访研究 

Public title:

The follow-up study of inflammatory bowel disease in children in China 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

我国儿童炎症性肠病的随访研究 

Scientific title:

The follow-up study of inflammatory bowel disease in children in China 

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:

张顺先 

研究负责人:

耿岚岚 

Applicant:

Zhang Shun-Xian 

Study leader:

Geng Lan-Lan 

申请注册联系人电话:

Applicant telephone:

+86 15221367406 

研究负责人电话:

Study leader's telephone:

+86 13622237569 

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:

zhangshunxian110@163.com 

研究负责人电子邮件:

Study leader's E-mail:

13622237569@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:

广东省广州市越秀区人民中路318号 

研究负责人通讯地址:

广东省广州市越秀区人民中路318号 

Applicant address:

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

Study leader's address:

318 Renmin Middle Road, Yuexiu District, Guangzhou city, 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:

2018021403 

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科研伦理委员会 

Name of the ethic committee:

Guangzhou Women and Children's Medical Center ethics 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:

李庆丰 

Contact Name of the ethic committee:

Li Qingfeng 

伦理委员会联系地址:

广东省广州市越秀区人民中路318号 

Contact Address of the ethic committee:

318 Renmin Road, Yuexiu 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:

广东省广州市越秀区人民中路318号 

Primary sponsor's address:

318 Renmin Middle Road, Yuexiu District, Guangzhou city, 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

市(区县):

广州

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:

广东省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 city, Guangdong, China

经费或物资来源:

自筹经费 

Source(s) of funding:

Self-financing 

研究疾病:

炎症性肠病 

Target disease:

Inflammatory bowel disease 

研究疾病代码:

 

Target disease code:

 

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:

其它 

Study phase:

N/A 

研究目的:

应用流行病学的随访技术和生物信息学技术,研究影响儿童IBD转归的影响因素(环境因素、遗传因素、治疗药物和方式、肠道微环境),为制定精准的个体化诊疗方案提供科学参考。 

Objectives of Study:

Epidemiological follow-up technology and bioinformatics technology were applied to study the influencing factors (IBD, environmental factors, genetic factors, therapeutic drugs and ways, intestinal microenvironment) that affect the prognosis of intestinal polyps children, so as to provide scientific references for precise individualized diagnosis and treatment. 

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:

入选标准:本研究选取广州市妇幼儿童医疗中心等作为研究现场。将门诊就诊或住院部的IBD的患者、且同意加入该研究的对象作为研究对象 

Inclusion criteria

Selection criteria: This study selected the Guangzhou woman and child medical center as the research site. The subjects of IBD in the outpatient department or inpatient department were agreed to be recrutied into this research, which used be as to research object. 

排除标准:

剔除标准:(1)未获得知情同意者;(2)排除粪便样品量不足、血液量不足或没有采集肠黏膜没有采集者、问卷不完整或拒绝参加的研究对象 

Exclusion criteria:

(1) who didn't agree to be recruted into this study; (2) subjects with inadequate fecal samples, inadequate blood volume, or no intestinal mucosa collection, incomplete questionnaires or refusal to participate. 

研究实施时间:

Study execute time:

From2000-01-01To 2027-12-31 

征募观察对象时间:

Recruiting time:

From2000-01-01To 2027-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

426

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

环境因素、遗传因素、治疗药物和方式、肠道微环境

指标类型:

主要指标 

Outcome:

IBD, environmental factors, genetic factors, therapeutic drugs and ways, intestinal microenvironment

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:

粪便

组织:

Sample Name:

Stool

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:

肠黏膜

组织:

Sample Name:

intestinal mucosa

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 0 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):

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):

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):

采用向机构伦理委员会索要的方法,在相关论文发表过程中或论文发表后索要原始数据

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

Requested to the institutional ethics committee, ask for the original data after the publication of the relevant papers or the publication of the papers

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:

数据库建立

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

Database establishment

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-03-11
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