今天是:2020-08-05 星期三

儿童肝移植样本库建设
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注册号:

Registration number:

ChiCTR2000034591 

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:

儿童肝移植样本库建设 

Public title:

Construction of the pediatric liver transplantation biobank 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

儿童肝移植样本库建设 

Scientific title:

Construction of the pediatric liver transplantation biobank 

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:

向征 

研究负责人:

赵耀 

Applicant:

Zheng Xiang 

Study leader:

Yao Zhao 

申请注册联系人电话:

Applicant telephone:

+86 17723191712 

研究负责人电话:

Study leader's telephone:

+86 13452358879 

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:

xiangzheng061@163.com 

研究负责人电子邮件:

Study leader's E-mail:

Zhaoy@cqmu.edu.cn 

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:

重庆市渝中区中山二路136号 

研究负责人通讯地址:

重庆市渝中区中山二路136号 

Applicant address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

Study leader's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

400014 

研究负责人邮政编码:

Study leader's postcode:

400014 

申请人所在单位:

重庆医科大学附属儿童医院 

Applicant's institution:

Children's Hospital of Chongqing Medical University 

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:

(2018)年伦审(研)第(120)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:

重庆医科大学附属儿童医院医学研究伦理委员会 

Name of the ethic committee:

Institutional Review Board of Children's Hospital of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-09-21 

伦理委员会联系人:

袁誉铭 

Contact Name of the ethic committee:

Yuming Yuan 

伦理委员会联系地址:

重庆市渝中区中山二路136路 

Contact Address of the ethic committee:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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:

重庆医科大学附属儿童医院 

Primary sponsor:

Children's Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区中山二路136号 

Primary sponsor's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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):

重庆市

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学附属儿童医院

具体地址:

重庆市渝中区中山二路136号

Institution
hospital:

Children's Hospital of Chongqing Medical University

Address:

136 Second Zhongshan Road, Yuzhong District

经费或物资来源:

重庆医科大学附属儿童医院 

Source(s) of funding:

Children's Hospital of Chongqing Medical University 

研究疾病:

儿童肝移植 

Target disease:

pediatric liver transplantation 

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:

建立我院前瞻性儿童肝移植生物样本库,规范样本采集及使用,为后续终末期肝病基因组学、蛋白质组学研究及构建儿童终末期肝病风险预警模型提供数据积累储备,提高我院儿童终末期肝病诊治水平。  

Objectives of Study:

To establish a biobank of pediatric liver transplantation(PLT) in our hospital, standardize sample collection and application, provide data accumulation and reserve for subsequent PLT genomics and proteomics studies, risk prediction models for pediatric liver transplantation events, and improve the diagnosis and treatment of PLT.  

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.确诊为终末期肝病的儿童; 2.在我院实施肝移植手术; 3.患者知情同意; 4.长期在我院随访。  

Inclusion criteria

1. Children diagnosed with end-stage liver disease; 2. Liver transplantation in our hospital; 3. informed patient consent; 4. long-term follow-up in our hospital. 

排除标准:

没有固定联系方式,难以随访的患者。 

Exclusion criteria:

Patient who lacks contact information, difficult to follow up the patients. 

研究实施时间:

Study execute time:

From2020-08-01To 2028-07-01 

征募观察对象时间:

Recruiting time:

From2020-08-01To 2025-07-01 

干预措施:

Interventions:

组别:

Case series

样本量:

1000

Group:

Case series

Sample size:

干预措施:

N

干预措施代码:

Intervention:

N

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆市 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属儿童医院 

单位级别:

三级甲等 

Institution
hospital:

Children’s Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

主要不良肝胆指标

指标类型:

主要指标 

Outcome:

Major adverse hepatobiliary indicators

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:

肝组织

Sample Name:

Blod

Tissue:

liver

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:

肝组织

组织:

Sample Name:

liver tissue

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:

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:

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 years
最大 Max age 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):

不适用

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

not applicable

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:

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):

本项目数据管理采用重庆医科大学附属儿童医院生物样本库管理系统

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

The biobank management system of CHCMU is used for data management of this project.

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:

研究者根据受试者的原始观察记录及就诊病历,将数据及时、完整、正确、清晰地载入病例报告表。 课题监督者确认所有病例报告表填写正确并与原始资料一致。如有错误和遗漏,及时要求研究者改正。修改时需保持原有记录清晰可见,改正处需经研究者签名并注明日期。 经过监查员检查后的病例报告表,由监查员核查签字后,及时送交临床研究数据管理员。 对于完成的病例报告表在研究者、监查员、数据管理员之间的传送应有专门的记录,收到时应有相应的签名,记录需妥善保存。 原始病例报告表在按要求完成数据录入和核查后,按编号的顺序归档保存,并填有检索目录等,以备查考。电子数据文件包括数据库、检查程序、分析程序、分析结果、编码本和说明文件等,应分类保存,并有多个备份保存于不同磁盘或记录介质上,妥善保存,防止损坏。

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

According to the original medical records of the subjects, the researchers document the data into the CRF timely, complete, correct and clear. Any question and accident during the data recording should be recorded and report in time for early dealing. After the data recording, spot check should be implemented to check the recording quality, analyze and deal with the problems. Raw CRF should be filed and stored according the code and fill the index for looking up after the recording and inspecting. Electronic data file package should be stored in different type, and stored with multiple backups in different hard disc or recording medium to prevent damage, including database, inspecting procedure, analysis procedure, code book and introduction files.

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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