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不同表型慢阻肺的生物标志物研究
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注册号:

Registration number:

ChiCTR1900022271 

最近更新日期:

Date of Last Refreshed on:

2019-04-02 

注册时间:

Date of Registration:

2019-04-02 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

不同表型慢阻肺的生物标志物研究 

Public title:

The biomarkers of different phenotypes of chronic obstructive pulmonary disease 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于多组学技术的慢阻肺分子分型标志物的筛查与早期诊断模式的构建 

Scientific title:

Screen molecular typing markers of COPD and construct early diagnosis model based on multi omics technology 

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:

秦江月 

研究负责人:

文富强 

Applicant:

Jiangyue Qin 

Study leader:

Fuqiang Wen 

申请注册联系人电话:

Applicant telephone:

+86 18081740652 

研究负责人电话:

Study leader's telephone:

+86 18980601258 

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:

584375592@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

wenfuqiang.scu@gmail.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:

四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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, 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:

2017(270) 

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分委会 

Name of the ethic committee:

Biomedical Ethic Committee of West China Hospital, Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-09-27 

伦理委员会联系人:

梁茂植 

Contact Name of the ethic committee:

Liang Maozhi 

伦理委员会联系地址:

四川省成都市武侯区国学巷37号 

Contact Address of the ethic committee:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

成都市国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

武侯区国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxue Lane, Wuhou District

经费或物资来源:

卫计委科技发展研究中心 

Source(s) of funding:

Research Center for science and technology development of Wei Planning Commission 

研究疾病:

慢性阻塞性肺疾病 

Target disease:

chronic obstructive pulmonary 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:

探究不同表型慢阻肺生物标志物及其临床价值。 

Objectives of Study:

Explore the biomarkers of different phenotypes of chronic obstructive pulmonary disease. 

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:

慢性阻塞性肺疾病患者纳入标准:1)年龄大于18周岁; 2)吸入支气管扩张剂后,符合GOLD诊断COPD标准。 对照者纳入标准:1)年龄大于18周岁; 2)查体及常规实验室检查正常; 3)胸部影像学检查正常; 4)肺功能正常:FVC, FEV1, FEV1/FVC, TLC, DLCO;5)心电图正常; 6)6个月内未使用治疗相关肺部疾病药物。 

Inclusion criteria

For COPD patients:1)Aged at least 18 years; 2)After inhalation of bronchodilator, COPD was diagnosed according to GOLD criteria. For control subjects:1)Aged at least 18 years; 2)Physical examination and routine laboratory examination are normal; 3)Chest radiography is normal; 4)Normal lung function: FVC, FEV1, FEV1/FVC, TLC, DLCO; 5)Normal electrocardiogram; 6)No drugs were used to treat lung diseases within 6 months. 

排除标准:

慢性阻塞性肺疾病患者及对照者排除标准:1)慢性肺部疾病,如哮喘;2)3个月内有急性肺部疾病发作; 3)恶性肿瘤病史。 

Exclusion criteria:

For COPD patients and control subjects:1) Chronic lung diseases, such as asthma;2) Acute exacerbation of pulmonary disease occurred within 3 months; 3) History of malignant tumors. 

研究实施时间:

Study execute time:

From2017-10-08To 2020-12-31 

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):

吸入支气管扩张剂后,符合GOLD诊断COPD标准。

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):

After inhalation of bronchodilator, COPD was diagnosed according to GOLD 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):

多组学技术。

Index test:

Multi omics technology.

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)

慢性阻塞性肺疾病患者。

例数:

Sample size:

800

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):

COPD patients.

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):

长期吸烟史,肺功能检查未达到COPD诊断标准。

例数:

Sample size:

100

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

Long-term smoking history, pulmonary function tests did not meet COPD diagnostic criteria.

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

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, Sichuan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

北京大学第三医院 

单位级别:

三甲医院 

Institution
hospital:

Peking University Third Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

中日友好医院 

单位级别:

三甲医院 

Institution
hospital:

China-Japan Friendship Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

济南 

Country:

China 

Province:

Shandong 

City:

Ji'nan 

单位(医院):

山东大学齐鲁医院 

单位级别:

三甲医院 

Institution
hospital:

QiLu Hospital of ShanDong University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学同济医学院附属同济医院 

单位级别:

三甲医院 

Institution
hospital:

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China 

Province:

Niaoling 

City:

Shenyang 

单位(医院):

中国医科大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

First Affiliated Hospital of China Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川省医学科学院·四川省人民医院 

单位级别:

三甲医院 

Institution
hospital:

Sichuan Academy of Medical Sciences and Sichuan People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川省肿瘤医院 

单位级别:

三甲医院 

Institution
hospital:

Sichuan Cancer Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

转录组学

指标类型:

主要指标 

Outcome:

transcriptomics

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

蛋白组学

指标类型:

主要指标 

Outcome:

proteomics

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

代谢组学

指标类型:

主要指标 

Outcome:

metabonomics

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:

血液

组织:

Sample Name:

blood

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:

肺组织

组织:

Sample Name:

lung tissue

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:

支气管肺泡灌洗液

组织:

Sample Name:

bronchoalveolar lavage fluid

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:

痰液

组织:

Sample Name:

sputum

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:

尿液

组织:

Sample Name:

urine

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:

粪便

组织:

Sample Name:

Feces

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:

鼻咽拭子

组织:

Sample Name:

nasopharyngeal 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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 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):

未使用

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

Not used

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

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):

通过ResMan公开, http://www.medresman.org

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

IPD will be public accessable via ResMan, http://www.medresman.org

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:

使用CRF表以及ResMan系统

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

CRF and ResMan system

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-02
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