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Clinical Study of a novel coronavirus nucleic acid assay based on LAMP isothermal amplification
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注册号:

Registration number:

ChiCTR2200060048 

最近更新日期:

Date of Last Refreshed on:

2022-05-16 

注册时间:

Date of Registration:

2022-05-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一种基于LAMP恒温扩增的新冠病毒核酸检测试剂的临床研究 

Public title:

Clinical Study of a novel coronavirus nucleic acid assay based on LAMP isothermal amplification 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一种基于LAMP恒温扩增的新冠病毒核酸检测试剂的临床研究 

Scientific title:

Clinical Study of a novel coronavirus nucleic acid assay based on LAMP isothermal amplification 

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:

陈英 

研究负责人:

李为民 

Applicant:

chenying 

Study leader:

liweimin 

申请注册联系人电话:

Applicant telephone:

02885422851 

研究负责人电话:

Study leader's telephone:

18980601009 

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:

hxlcyjglb@163.com 

研究负责人电子邮件:

Study leader's E-mail:

weimi003@yahoo.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:

四川大学华西医院 

研究负责人通讯地址:

四川大学华西医院 

Applicant address:

#37 Guoxue Alley, Wuhou District, Chengdu, Sichuan Province, P.R.China 

Study leader's address:

#37 Guoxue Alley, Wuhou District, Chengdu, Sichuan Province, P.R.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:

四川大学华西医院 

Applicant's institution:

West China Hospital of Sichuan 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:

2022年审(780)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:

四川大学华西医院生物医学伦理审查委员会 

Name of the ethic committee:

Ethics Committee on Biomedical Research, West China Hospital of Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2022-05-13 

伦理委员会联系人:

左泽锦 

Contact Name of the ethic committee:

zuozejin 

伦理委员会联系地址:

四川省成都市武侯区国学巷37号老八教412 

Contact Address of the ethic committee:

#37 Guoxue Alley, Wuhou District, Chengdu, Sichuan Province, P.R.China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

02885422654 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

huaxilunli@163.com 

研究实施负责(组长)单位:

四川大学华西医院 

Primary sponsor:

West China Hospital of Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号 

Primary sponsor's address:

#37 Guoxue Alley, Wuhou District, Chengdu, Sichuan Province, P.R.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):

四川省

市(区县):

成都市

Country:

CHINA

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

四川省成都市武侯区国学巷37号

Institution
hospital:

West China Hospital of Sichuan University

Address:

#37 Guoxue Alley, Wuhou District, Chengdu, Sichuan Province, P.R.China

经费或物资来源:

四川大学“医学+制造”中心 

Source(s) of funding:

Med-X Center for Materials 

研究疾病:

Corona Virus Disease 2019 

Target disease:

Corona Virus Disease 2019 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

利用微流控芯片整合一步法裂解及等温扩增技术实现新冠病毒的快速床旁/居家检测。 

Objectives of Study:

Using microfluidic chip to integrate one-step lysis and isothermal amplification technology to achieve rapid bedside/home detection of 2019-nCoV 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

诊断试验诊断准确性 

Study design:

Diagnostic test for accuracy 

纳入标准:

新冠疑似病例 

Inclusion criteria

Suspected cases of 2019-nCoV 

排除标准:

无自主授权能力、因鼻腔疾病等无法取样或难以取样的患者。 

Exclusion criteria:

Patients who are unable or difficult to take samples due to nasal diseases or without autonomous authorization 

研究实施时间:

Study execute time:

From2022-05-16To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2022-05-16To 2022-12-31 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

核酸荧光法检测

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Nucleic acid fluorescence detection

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

等温扩增技术实现新冠病毒的快速床旁/居家检测

Index test:

Isothermal amplification technology realizes rapid bedside/home detection of 2019-nCoV

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

新冠疑似病例

例数:

Sample size:

1000

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Suspected cases of 2019-nCoV

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

成都市 

Country:

CHINA 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三甲医院 

Institution
hospital:

West China Hospital of Sichuan University  

Level of the institution:

Grade III Class A hospital 

国家:

中国 

省(直辖市):

四川省 

市(区县):

广安市 

Country:

CHINA 

Province:

Sichuan 

City:

Guangan 

单位(医院):

广安市人民医院 

单位级别:

三甲医院 

Institution
hospital:

Guang'an Peoples Hospital  

Level of the institution:

Grade III Class A hospital 

测量指标:

Outcomes:

指标中文名:

新型冠状病毒检测结果

指标类型:

主要指标 

Outcome:

2019-nCoV test results

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

灵敏度

指标类型:

主要指标 

Outcome:

Sensitivity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

特异度

指标类型:

主要指标 

Outcome:

Specificity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

阳性预测值

指标类型:

主要指标 

Outcome:

Positive predictive value

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

阴性预测值

指标类型:

主要指标 

Outcome:

Negative predictive value

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:

鼻拭子

组织:

Sample Name:

Nasal Swab

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 0 years
最大 Max age 100 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):

盲法:

Blinding:

是否共享原始数据:

IPD sharing

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):

不共享

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

no sharing

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:

病历

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

medical records

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2022-05-16
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