今天是:2020-06-06 星期六

付亮医师: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。 基于新型呼出气高通量质谱分析的新型冠状病毒肺炎(COVID-19)早期快速检测技术研究
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注册号:

Registration number:

ChiCTR2000029695 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

付亮医师: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。 基于新型呼出气高通量质谱分析的新型冠状病毒肺炎(COVID-19)早期快速检测技术研究 

Public title:

Early Detection of Novel Coronavirus Pneumonia (COVID-19) Based on a Novel High-Throughput Mass Spectrometry Analysis With Exhaled Breath 

注册题目简写:

新冠肺炎呼出气检测研究 

English Acronym:

COVID-19 detection by VOC 

研究课题的正式科学名称:

基于新型呼出气挥发性代谢物的高通量质谱分析的新型冠状病毒肺炎(COVID-19)的早期快速检测技术研究 

Scientific title:

Early Detection of Novel Coronavirus Pneumonia (COVID-19) Based on a Novel High-Throughput Mass Spectrometry Analysis With Volatile Organic Compounds in Exhaled Breath 

研究课题代号(代码):

Study subject ID:

NCP-VOC 

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:

付亮 

研究负责人:

邓国防 

Applicant:

Fu Liang 

Study leader:

Deng Guofang 

申请注册联系人电话:

Applicant telephone:

+86 15989869571 

研究负责人电话:

Study leader's telephone:

+86 13530027001 

申请注册联系人传真 :

Applicant Fax:

+86 0755-61238928 

研究负责人传真:

Study leader's fax:

+86 0755-61238928 

申请注册联系人电子邮件:

Applicant E-mail:

flk1981@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

jxxk1035@yeah.net 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.szdsyy.com/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.szdsyy.com/ 

申请注册联系人通讯地址:

广东省深圳市龙岗区布澜路29号 

研究负责人通讯地址:

广东省深圳市龙岗区布澜路29号 

Applicant address:

29 Bulan Road, Longgang District, Shenzhen, Guangdong, China 

Study leader's address:

29 Bulan Road, Longgang District, Shenzhen, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

518000 

研究负责人邮政编码:

Study leader's postcode:

518000 

申请人所在单位:

深圳市第三人民医院肺病二科 

Applicant's institution:

Pulmonary Diseases Department, Shenzhen Third 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:

深圳市第三人民医院 

Primary sponsor:

Shenzhen Third People's Hospital 

研究实施负责(组长)单位地址:

广东省深圳市龙岗区布澜路29号深圳市第三人民医院 

Primary sponsor's address:

29 Bulan Road, Longgang District, Shenzhen, 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):

广东省

市(区县):

深圳市

Country:

China

Province:

Gunagdong

City:

Shenzhen

单位(医院):

深圳市第三人民医院

具体地址:

龙岗区布澜路29号

Institution
hospital:

Shenzhen Third People's Hospital

Address:

29 Bulan Road, Longgang District

国家:

中国

省(直辖市):

广东省

市(区县):

深圳市

Country:

China

Province:

Gunagdong

City:

Shenzhen

单位(医院):

深圳市步锐生物科技有限公司

具体地址:

坪山新区金辉路14号坪山生物医药企业加速器10号楼904房间

Institution
hospital:

Shenzhen Breatha Biological Technology Co.,Ltd.

Address:

Room 904, Building 10, Pingshan Biomedical Enterprise Accelerator, 14 Jinhui Road, Pingshan New District

经费或物资来源:

国家感染性疾病临床医学研究中心 

Source(s) of funding:

National Clinical Research Center for Infectious Disease 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

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:

针对新型冠状病毒肺炎早期快速检测的迫切需求,本团队拟开展探索性诊断研究,采用真空紫外光电离及化学电离在线质谱检测技术(本团队具有完全自主知识产权,解决了呼出气的质谱直接进样、给出定性定量分析,为全球首创和独有技术),攻克呼出气精准采样、高覆盖度软电离源、基于质谱大数据的诊断模型构建等核心关键问题,研制基于新型呼出气高通量质谱分析的新型冠状病毒肺炎的早期快速检测技术。 

Objectives of Study:

In response to the urgent need for early detection of Novel Coronavirus Pneumonia (NCP), we intend to carry out exploratory diagnostic research using online mass spectrometry (MS) technology. The MS adopts a novel combined ion source based on a vacuum ultraviolet lamp with both photoionization and chemical ionization. We have completely independent intellectual property rights, enabling direct injection of exhaled breath in MS and providing qualitative and quantitative analysis, which are the world's first and unique technology. To overcome core issues such as accurate sampling of exhaled breath, high-coverage soft ionization source, and construction of diagnostic models based on mass spectrometric big data, we are committed to developing high-throughput MS for novel early detection of NCP. 

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:

新型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。 结合下述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天内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天内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)聚集性发病; (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

Suspected cases of pneumonitis with the novel coronavirus infection. Suspected case criteria: Any one of the following epidemiological histories meets any two of the clinical manifestations: Comprehensive analysis 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 with case reports within 14 days before the onset of illness; (2) Onset of illness Patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports in the previous 14 days; (3) Aggressive onset; (4) History of contact with new coronavirus infection. People with a new coronavirus infection are those who test positive for nucleic acid. 2. Clinical manifestations (1) fever and/or respiratory symptoms; (2) with the imaging mentioned above characteristics of pneumonia; (3) the total number of white blood cells is normal or decreased in the early stage of onset, or the lymphocyte count is decreased. 

排除标准:

不能获取呼出气样本的重症新冠肺炎患者。 

Exclusion criteria:

Severe novel coronavirus pneumonia patients who cannot provide exhaled breath samples. 

研究实施时间:

Study execute time:

From2020-03-01To 2021-03-31 

诊断试验:

Diagnostic Tests:

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

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):

RT-PCR of the novel coronavirus

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):

呼出气质谱检测

Index test:

Exhaled breath detection by mass spectrometry

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)

新冠肺炎疑似病例

例数:

Sample size:

300

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

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:

Other pneumonia patients infected by pathogenic microorganisms other than novel coronavirus

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):

深圳市第三人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shenzhen Third People's Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

新冠肺炎检测敏感性

指标类型:

主要指标 

Outcome:

Sensitivity of detection of NCP

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新冠肺炎检测特异性

指标类型:

主要指标 

Outcome:

Specificity of detection of NCP

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:

呼出气

组织:

Sample Name:

Exhaled Breath

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 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):

No randomazition.

盲法:

未说明

Blinding:

Not stated

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):

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:

Electric Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-10
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