今天是:2019-07-21 星期日

Quantitative rotating frame relaxometry for early detection of liver fibrosis in presence of hepatic iron
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注册号:

Registration number:

ChiCTR1900022055 

最近更新日期:

Date of Last Refreshed on:

2019-03-22 

注册时间:

Date of Registration:

2019-03-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

Quantitative rotating frame relaxometry for early detection of liver fibrosis in presence of hepatic iron 

Public title:

Quantitative rotating frame relaxometry for early detection of liver fibrosis in presence of hepatic iron 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Quantitative rotating frame relaxometry for early detection of liver fibrosis in presence of hepatic iron 

Scientific title:

Quantitative rotating frame relaxometry for early detection of liver fibrosis in presence of hepatic iron 

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:

Weitian Chen 

研究负责人:

Weitian Chen 

Applicant:

Weitian Chen 

Study leader:

Weitian Chen 

申请注册联系人电话:

Applicant telephone:

+852 35056000 

研究负责人电话:

Study leader's telephone:

+852 35056000 

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:

wtchen@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

wtchen@cuhk.edu.hk 

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:

中國香港特別行政區新界沙田威爾士親王醫院包玉剛爵士癌症中心LG樓15室 

研究负责人通讯地址:

中國香港特別行政區新界沙田威爾士親王醫院包玉剛爵士癌症中心LG樓15室 

Applicant address:

Room 15, LG/F, Sir Yue Kong Pao Centre for Cancer, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China 

Study leader's address:

Room 15, LG/F, Sir Yue Kong Pao Centre for Cancer, Prince of Wales Hospital, Shatin, N.T., Hong Kong, 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:

香港中文大學 

Applicant's institution:

The Chinese University of Hong Kong 

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:

2018.235 

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:

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會 

Name of the ethic committee:

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

Jenny Ng 

Contact Name of the ethic committee:

Jenny Ng 

伦理委员会联系地址:

中國香港特別行政區新界沙田威爾士親王醫院呂志和臨床科學大樓8/F 

Contact Address of the ethic committee:

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T., Hong Kong, 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:

香港中文大學 

Primary sponsor:

The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

中國香港特別行政區新界沙田威爾士親王醫院G樓27023室 

Primary sponsor's address:

Rm 27023, G/F, Prince of Wales Hospital, Shatin, N.T., Hong Kong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

Health and Medical Research Fund 

Source(s) of funding:

Health and Medical Research Fund 

研究疾病:

肝纖維化 

Target disease:

liver fibrosis 

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:

1. To evaluate the prevalence of iron deposition in patient at early stage of liver fibrosis and its effect on standard T1rho quantification in liver; 2. To develop T1rho quantification method to correct shortening effect due to presence of iron and evaluate it on the patient cohorts for diagnosis of early stage liver fibrosis. 

Objectives of Study:

1. To evaluate the prevalence of iron deposition in patient at early stage of liver fibrosis and its effect on standard T1rho quantification in liver; 2. To develop T1rho quantification method to correct shortening effect due to presence of iron and evaluate it on the patient cohorts for diagnosis of early stage liver fibrosis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

Aged 18 to 55 years; Informed written consent obtained 

Inclusion criteria

Aged 18 to 55 years; Informed written consent obtained 

排除标准:

Contraindications to MRI such as the presence of metallic implants, claustrophobia and pregnancy 

Exclusion criteria:

Contraindications to MRI such as the presence of metallic implants, claustrophobia and pregnancy 

研究实施时间:

Study execute time:

From2019-04-01To 2021-03-31 

干预措施:

Interventions:

组别:

Case series

样本量:

50

Group:

Case series

Sample size:

干预措施:

N/A

干预措施代码:

Intervention:

NOT APPLICABLE

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

威爾士親王醫院 

单位级别:

威爾士親王醫院 

Institution
hospital:

Prince of Wales Hospital  

Level of the institution:

Prince of Wales Hospital 

测量指标:

Outcomes:

指标中文名:

MR T1rho

指标类型:

主要指标 

Outcome:

MR T1rho

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

iron content of liver

指标类型:

主要指标 

Outcome:

iron content of liver

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:

组织:

Sample Name:

NOT APPLICABLE

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 18 years
最大 Max age 55 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):

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

NOT APPLICABLE

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:

NOT APPLICABLE

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-03-22
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