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Effects of smoking cessation on tobacco-induced airway epithelial injury and mucin expression
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注册号:

Registration number:

ChiCTR2100054772 

最近更新日期:

Date of Last Refreshed on:

2021-12-26 

注册时间:

Date of Registration:

2021-12-26 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

此为补注册,需在http://www.medresman.org.cn上建立项目、审核原始数据并公示后才能补注册 戒烟对烟草诱导的气道上皮损伤及粘蛋白表达的影响及干预研究 

Public title:

Effects of smoking cessation on tobacco-induced airway epithelial injury and mucin expression 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

戒烟对烟草诱导的气道上皮损伤及粘蛋白表达的影响及干预研究 

Scientific title:

Effects of smoking cessation on tobacco-induced airway epithelial injury and mucin expression 

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:

胥韦 

研究负责人:

胥韦 

Applicant:

Xu Wei 

Study leader:

Xu Wei 

申请注册联系人电话:

Applicant telephone:

13688815411 

研究负责人电话:

Study leader's telephone:

13688815411 

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:

xuw@hku-szh.org 

研究负责人电子邮件:

Study leader's E-mail:

xuw@hku-szh.org 

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:

中国广东省深圳市福田区海园一路1号 

研究负责人通讯地址:

中国广东省深圳市福田区海园一路1号 

Applicant address:

The University of Hong Kong - Shenzhen Hospital, 1, Haiyuan 1st Road, Futian District, Shenzhen, Guangdong, P.R.C. 

Study leader's address:

The University of Hong Kong - Shenzhen Hospital, 1, Haiyuan 1st Road, Futian District, Shenzhen, Guangdong, P.R.C. 

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:

香港大学深圳医院 

Applicant's institution:

The University of Hong Kong - Shenzhen 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:

伦【2019】037 

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:

香港大学深圳医院医学研究伦理委员会 

Name of the ethic committee:

Ethics Committee of The University of Hong Kong - Shenzhen Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-02-27 

伦理委员会联系人:

王静贤 

Contact Name of the ethic committee:

Wang Jinxian 

伦理委员会联系地址:

中国广东省深圳市福田区海园一路1号 

Contact Address of the ethic committee:

The University of Hong Kong - Shenzhen Hospital, 1, Haiyuan 1st Road, Futian District, Shenzhen, Guangdong, P.R.C. 

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:

香港大学深圳医院 

Primary sponsor:

The University of Hong Kong - Shenzhen Hospital 

研究实施负责(组长)单位地址:

中国广东省深圳市福田区海园一路1号 

Primary sponsor's address:

The University of Hong Kong - Shenzhen Hospital, 1, Haiyuan 1st Road, Futian District, Shenzhen, Guangdong, P.R.C. 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

深圳市卫计委医疗卫生“三名工程” 

Source(s) of funding:

Shenzhen 

研究疾病:

肺损伤 

Target disease:

Lung injury 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

1.研究戒烟对烟草诱导的气道炎症细胞、炎症因子及气道粘蛋白MUC5AC、MUC5B等气道粘液蛋白表达的影响。 2.评估戒烟后患者咳嗽评分及肺功能的影响。 3.研究戒烟前后、戒烟(或减少烟草摄入)后不同时间点气道炎症及气道粘蛋白表达的变化。 

Objectives of Study:

1. To study the effects of smoking cessation on tobacco-induced airway inflammatory cells, inflammatory factors, and airway mucin MUC5AC, MUC5B and other airway mucus protein expression. 2. Assess the impact of patients' cough score and lung function after smoking cessation. 3. To study the changes in airway inflammation and airway mucin expression at different time points before and after smoking cessation. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

1.男性,年龄30-65岁之间 2.目前吸烟,吸烟指数≥10包年 2.自愿和有能力签署知情同意书 

Inclusion criteria

1. Male, between 30-65 years old 2.Current smokers, smoking index ≥ 10 pack years 3. Voluntary and capable of signing informed consent 

排除标准:

1.不能合作或不能依从访视安排的患者 2.具有明确其他慢性呼吸道疾病史(慢性支气管炎、COPD除外) 3.严重不稳定的其它系统疾病者 

Exclusion criteria:

1. Patients who cannot cooperate or cannot follow the visit arrangement 2. Have a clear history of other chronic respiratory diseases (except chronic bronchitis and COPD) 3. With severely unstable other system diseases 

研究实施时间:

Study execute time:

From2019-05-01To 2022-04-30 

征募观察对象时间:

Recruiting time:

From2019-06-01To 2022-02-28 

干预措施:

Interventions:

组别:

非吸烟健康对照组

样本量:

20

Group:

Non-smoking healthy control group

Sample size:

干预措施:

None

干预措施代码:

Intervention:

None

Intervention code:

组别:

吸烟组

样本量:

80

Group:

Smoking group

Sample size:

干预措施:

戒烟

干预措施代码:

Intervention:

smoking cessation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

气道炎症细胞、炎症因子

指标类型:

主要指标 

Outcome:

Airway inflammatory cells, inflammatory factors

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

气道粘蛋白MUC5AC、MUC5B

指标类型:

主要指标 

Outcome:

Airway mucin MUC5AC, MUC5B

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

戒烟后患者咳嗽评分

指标类型:

主要指标 

Outcome:

Cough score of patients after smoking cessation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

戒烟后肺功能

指标类型:

主要指标 

Outcome:

Lung function after smoking cessation

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:

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:

血清

组织:

Sample Name:

serum

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 30 years
最大 Max age 65 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

根据是否吸烟进行分组,无需随机

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

Groups are based on whether they smoke or not, no need to randomize

盲法:

Blinding:

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

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):

NO

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

NO

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:

通过病例记录表(Case Record Form, CRF)进行数据采集和管理

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

Data collection and management through Case Record Form (CRF)

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-12-26
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