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Nanopore sequencing technique for the diagnosis of central nervous system infections
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注册号:

Registration number:

ChiCTR1900027620 

最近更新日期:

Date of Last Refreshed on:

2019-11-21 

注册时间:

Date of Registration:

2019-11-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

李玮医师:该研究的伦理审批文件未上传,请尽快上传并填写伦理审批日期。 纳米孔测序技术在中枢神经系统感染中的诊断性研究 

Public title:

Nanopore sequencing technique for the diagnosis of central nervous system infections 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

纳米孔测序技术在中枢神经系统感染中的诊断性研究 

Scientific title:

Nanopore sequencing technique for the diagnosis of central nervous system infections 

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:

李玮 

研究负责人:

李玮 

Applicant:

Wei Li 

Study leader:

Wei Li 

申请注册联系人电话:

Applicant telephone:

+86 13939061069 

研究负责人电话:

Study leader's telephone:

+86 13939061069 

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:

liwein@zzu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

liwein@zzu.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:

河南省郑州市金水区纬五路7号 

研究负责人通讯地址:

河南省郑州市金水区纬五路7号 

Applicant address:

7 Weiwu Road, Jinshui District, Zhengzhou, He'nan, China 

Study leader's address:

7 Weiwu Road, Jinshui District, Zhengzhou, He'nan, China 

申请注册联系人邮政编码:

Applicant postcode:

450003 

研究负责人邮政编码:

Study leader's postcode:

450003 

申请人所在单位:

郑州大学人民医院,河南省人民医院 

Applicant's institution:

People's Hospital of Zhengzhou University, He'nan Provincial People's Hospital 

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:

(2019)伦审第(55)号 

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:

河南省人民医院伦理委员会 

Name of the ethic committee:

The Ethical Committee of Henan Provincial People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

邵凤民 

Contact Name of the ethic committee:

Fengmin Shao 

伦理委员会联系地址:

河南省郑州市金水区纬五路7号郑州大学人民医院(河南省人民医院),450003 

Contact Address of the ethic committee:

People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, 7 Weiwu Road, Zhengzhou, He'nan, 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:

河南省人民医院 

Primary sponsor:

Henan Provincial People's Hospital 

研究实施负责(组长)单位地址:

河南省郑州市金水区纬五路7号 

Primary sponsor's address:

7 Weiwu Road, Zhengzhou, He'nan, 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):

河南

市(区县):

郑州

Country:

China

Province:

He'nan

City:

Zhengzhou

单位(医院):

河南省人民医院

具体地址:

金水区纬五路7号

Institution
hospital:

Henan Provincial People's Hospital

Address:

7 Weiwu Road, Jinshui District

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

研究疾病:

中枢神经系统感染性疾病 

Target disease:

central nervous system infectious disease 

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:

进行纳米孔测序技术在中枢神经系统感染中的诊断性研究,同期将纳米孔测序技术与其他病原检测方法进行比较分析。 

Objectives of Study:

To perform a diagnostic test using the nanopore sequencing technique for the diagnosis of central nervous system infections and evaluate the performance of the nanopore sequencing technique in comparison with other microbiologic tests. 

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:

本研究中脑炎的诊断标准如下:主要标准:精神状态改变(定义为意识水平下降或改变,嗜睡,或人格改变)持续≥24小时,除外其他原因;和/或癫痫发作,除外既往癫痫所致或单纯性热性惊厥。次要标准(符合2条诊断可能的脑炎,符合≥3条诊断很可能的脑炎: (1)起病前或起病后72小时内记录到≥38℃的发热; (2)新出现的神经系统局灶性表现; (3)脑脊液白细胞≥5/mm3; (4)神经影像显示脑实质病灶(较前新出现或本次起病新出现),提示脑炎; (5)脑电图异常,提示脑炎,除外其他原因所致。 本研究中脑膜炎的诊断标准:符合≥2条以下临床表现:(1)头痛,(2)发热(起病前或起病后72小时内记录到≥38℃),(3)颈强,(4)意识水平下降(Glasgow昏迷评分<14分);且经腰穿证实(脑脊液白细胞≥5/mm3)。 

Inclusion criteria

Case definitions for encephalitis: Major criteria (required) Patients presenting to medical attention with altered mental status (decreased or altered level of consciousness or personality change) lasting >=24 hrs with no alternative cause identified, and/or generalized or partial seizures not fully attributable to a pre-existing seizure disorder or a simple febrile seizure. Minor criteria (>=2 points) Documented fever >=38 degree C within the 72 hrs before or after presentation New onset of focal neurologic findings CSF WBC count >=5/cubic mm Abnormality of brain parenchyma on neuroimaging suggestive of encephalitis that is either new from prior studies or appears acute in onset Abnormality on EEG that is consistent with encephalitis and not attributable to another cause; Case definitions for meningitis Patients presenting to medical attention with at least two of the four symptoms of headache, fever (documented fever >=38 degree C within the 72 hrs before or after presentation), neck stiffness, decreased level of consciousness (defined by a Glasgow Coma Scale score below 14) CSF white blood cell count >= 5/cubic mm. 

排除标准:

本研究中关于脑炎的排除标准:年龄≤28天;非感染性脑炎,如自身免疫性脑炎、副肿瘤性边缘性脑炎、视神经脊髓炎谱系疾病、风湿免疫病(系统性红斑狼疮、贝赫切特病、系统性血管炎等)神经系统受累;HIV、梅毒感染;近期(起病4周以内)疫苗接种史;无脑实质受累的脑膜炎;存在腰穿绝对禁忌,无法获取脑脊液;损伤所致明显血性脑脊液;或拒绝签署知情同意书。 本研究中关于脑膜炎的排除标准:年龄≤28天;HIV、梅毒感染;脑脊液细胞学证实脑膜恶性肿瘤;损伤所致明显血性脑脊液;或拒绝签署知情同意书。 

Exclusion criteria:

Exclusion criteria for encephalitis: <=28 days of age; Non-infectious encephalitis, such as autoimmune disorders, paraneoplastic syndromes, NMOSD, neuropsychiatric involvement of rheumatic diseases HIV or syphilis infection History of recent (within 4 weeks before the onset of disease) vaccination Meningitis without clinical brain parenchyma involvement Absolute contraindications for lumbar puncture; Traumatic LP with obvious blood-contaminated CSF Pregnancy Refusal to sign the informed consent. Exclusion criteria for meningitis: <=28 days of age; HIV or syphilis infection Meningeal malignancy confirmed by CSF cytology Traumatic LP with obvious blood-contaminated CSF Pregnancy Refusal to sign the informed consent. 

研究实施时间:

Study execute time:

From2019-12-01To 2021-12-01 

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):

本研究中脑炎、脑膜炎的诊断标准如纳入标准所述。

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):

The diagnostic criteria of encephalitis and meningitis are as described in the inclusion criteria.

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):

纳米孔测序技术

Index test:

nanopore sequencing technique

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)

脑炎、脑膜炎患者。

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):

Patients with encephalitis or meningitis.

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:

30

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):

河南 

市(区县):

郑州 

Country:

China 

Province:

Henan 

City:

Zhengzhou 

单位(医院):

郑州大学人民医院,河南省人民医院 

单位级别:

三级甲等 

Institution
hospital:

People's Hospital of Zhengzhou University, Henan Provincial People's Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

灵敏度,特异度,误诊率,漏诊率,阳性预测值,阴性预测值,正确率,约登指数,比数积,阳性似然比,阴性似然比

指标类型:

主要指标 

Outcome:

sensitivity,specificity,mistake diagnostic rate,pmission diagnostic rate,positive predictive value,negative predictive value,accuracy,Youden index,odd product,positive likelihood ratio,negative likelyhood ratio

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:

脑脊液

组织:

Sample Name:

cerebrospinal 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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 1 years
最大 Max age 90 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):

本研究为临床诊断性实验,不涉及随机方法。

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

This study is a clinical diagnostic test, which is not involved with randomization procedure.

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):

原始数据公开时间:

The time of sharing IPD:

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):

实验正在进行,原始数据尚未公开。

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

The study is ongoing, so IPD has not been shared yet.

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:

病例记录表

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-11-21
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