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Clinical study of a novel high sensitivity nucleic acid assay for novel coronavirus pneumonia (COVID-19) based on CRISPR-cas protein
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注册号:

Registration number:

ChiCTR2000029810 

最近更新日期:

Date of Last Refreshed on:

2020-02-14 

注册时间:

Date of Registration:

2020-02-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

黄卫人医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 基于CRISPR-Cas蛋白的高灵敏度新型冠状病毒肺炎(COVID-19)核酸检测技术的临床研究 

Public title:

Clinical study of a novel high sensitivity nucleic acid assay for novel coronavirus pneumonia (COVID-19) based on CRISPR-cas protein 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于CRISPR-Cas蛋白的高灵敏度新型冠状病毒肺炎(COVID-19)核酸检测技术开发与应用研究 

Scientific title:

Development and application of a novel high sensitivity nucleic acid assay for novel coronavirus pneumonia (COVID-19) based on CRISPR-cas protein 

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:

黄卫人 

研究负责人:

黄卫人 

Applicant:

Weiren Huang 

Study leader:

Weiren Huang 

申请注册联系人电话:

Applicant telephone:

+86 13923781386 

研究负责人电话:

Study leader's telephone:

+86 13923781386 

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:

pony8980@163.com 

研究负责人电子邮件:

Study leader's E-mail:

pony8980@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:

深圳市福田区笋岗西路3002号 

研究负责人通讯地址:

深圳市福田区笋岗西路3002号 

Applicant address:

3002 Sungang Road West, Futian District, Shenzhen 

Study leader's address:

3002 Sungang Road West, Futian District, Shenzhen 

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:

深圳市第二人民医院 

Applicant's institution:

Shenzhen Second People's Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic 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:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

深圳市第二人民医院 

Primary sponsor:

Shenzhen Second People's Hospital 

研究实施负责(组长)单位地址:

深圳市福田区笋岗西路3002号 深圳市第二人民医院 

Primary sponsor's address:

3002 Sungang Road West, Futian District, Shenzhen 

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):

深圳市

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

深圳市第二人民医院

具体地址:

福田区笋岗西路3002号

Institution
hospital:

Shenzhen Second People's Hospital

Address:

3002 Sungang Road West, Futian District

经费或物资来源:

国家重点研发计划,广东省高水平医院建设资金,深圳市三名工程建设资金 

Source(s) of funding:

National Key R&D Program of China (2019YFA0906000), High level hospital construction fund of Guangdong Province, Sanming Project of Medicine in Shenzhen 

研究疾病:

新型冠状病毒肺炎 

Target disease:

Novel Coronavirus Pneumonia (COVID-19) 

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:

探索性研究/预试验 

Study phase:

研究目的:

新型冠状病毒感染的肺炎诊断的金标准是核酸检测技术,但是,目前基于RT-PCR的核酸检测技术明显存在敏感度低等问题(王辰院士估计在新型冠状病毒肺炎真实病例当中,核酸检测只有30%-50%阳性率),本团队拟进行探索性诊断研究,采用基于CRISPR-cas蛋白的核酸检测技术对临床使用的常规RT-PCR扩增产物做进一步的检测,可以增加核酸检测的灵敏度,降低核酸检测产生的假阴性结果。对病人的快速确诊具有重要的意义。 

Objectives of Study:

The gold standard for the diagnosis of COVID-19 is nucleic acid testing technology, however, the current nucleic acid detection technology based on RT-PCR has obviously low sensitivity (Chen Wang estimates that in the true case of COVID-19, nucleic acid testing is only 30%-50% positive rate). Our team intends to carry out exploratory diagnostic research. The use of CRISPR-cas protein-based nucleic acid detection technology for clinical use of conventional RT-PCR amplification of the material for further detection, can increase the sensitivity of nucleic acid detection, reduce the nucleic acid testing of false negative results. It is of great significance for the patient's rapid diagnosis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

新型的冠状病毒肺炎疑似病例。疑似病例标准:有以下流行病学史中的任何一条,符合临床表现中任意2条。 结合流行病学史和临床表现综合分析: 1.流行病学史 (1)发病前14个月有武汉市及周边地区,或其他有病例报告社区的旅行史或居住史; (2)发病前14发作曾接触过来自武汉市及周边地区,或来自有病例报告社区的发热或有呼吸道症状的患者; (3)聚集性发作; (4)与新型冠状病毒感染者有接触史。新型冠状病毒感染者是指病原核酸检测阳性者。 2.临床表现 (1)发热和/或呼吸道症状; (2)具有上述肺炎影像学特征; (3)发病早期白细胞总数正常或降低,或淋巴细胞计数减少。 

Inclusion criteria

Pneumonia cases with suspected SARS-CoV-2have either of the following epidemiological histories consistent with the following two clinical manifestations: A comprehensive analysis was conducted based on the following epidemiological history and clinical manifestations 1. Epidemiological history (1) Travel history or residence history of wuhan and surrounding areas or other communities shall provide case reports within 14 days before the onset of the disease; (2) Cases have been reported in the past 14 days in patients with fever or respiratory symptoms in community residents of wuhan and surrounding areas; (3) Aggressive attack; (4) History of exposure to new coronavirus infections people with new coronavirus infections are those who have tested positive for nucleic acid; 2. Clinical manifestations (1) Fever and/or respiratory symptoms; (2) Pneumonia with the above imaging features; (3) The total number of white blood cells was normal or decreased or the number of lymphocytes decreased at the initial stage of the disease. 

排除标准:

无法采集肺泡灌洗液、 深部痰、咽拭子、鼻拭子的疑似病人。 

Exclusion criteria:

Suspected patients with inability to collect deep sputum, throat swabs, or nose swabs from alveolar lavage. 

研究实施时间:

Study execute time:

From2020-02-16To 2020-03-20 

征募观察对象时间:

Recruiting time:

From2020-02-16To 2020-02-19 

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):

新冠肺炎病毒核酸检测, RT-PCR

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 test for new coronavirus, RT-PCR

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):

新型冠状病毒的RT-PCR产物

Index test:

RT-PCR product of SARS-CoV-2.

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)

新型冠状病毒肺炎疑似病例

例数:

Sample size:

10000

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 novel coronavirus pneumonia (COVID-19).

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):

其他病原体感染的肺炎患者

例数:

Sample size:

300

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

Pneumonia patients infected with other pathogens.

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):

深圳市 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

深圳市第二人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shenzhen Second People's Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

SEN, SPE, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, AUC of ROC

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:

鼻咽拭子

组织:

Sample Name:

Nasopharyngeal swabs

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:

组织:

Sample Name:

phlegm

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:

肺泡灌洗液

组织:

Sample Name:

Alveolar lavage fluid

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 1 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):

无随机分组

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

Non-randomization.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

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):

https://www.ncbi.nlm.nih.gov/

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

https://www.ncbi.nlm.nih.gov/

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:

电子病例记录表

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

Electronic case records

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-14
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