中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600126851
最近更新日期： Date of Last Refreshed on：	2026-06-17 11:41:17
注册时间： Date of Registration：	2026-06-17 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	具有地域及多民族特征的慢性呼吸系统疾病精准分型及前沿诊疗技术研究
Public title：	Research on Precise Classification and Advanced Diagnosis and Treatment Technologies for Chronic Respiratory Diseases with Regional and Multi-Ethnic Characteristics
注册题目简写：
English Acronym：
研究课题的正式科学名称：	具有地域及多民族特征的慢性呼吸系统疾病精准分型及前沿诊疗技术研究
Scientific title：	Research on Precise Classification and Advanced Diagnosis and Treatment Technologies for Chronic Respiratory Diseases with Regional and Multi-Ethnic Characteristics
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：	武佳璇	研究负责人：	李为民
Applicant：	Wu Jiaxuan	Study leader：	Li Weimin
申请注册联系人电话： Applicant telephone：	+86 17844613497	研究负责人电话： Study leader's telephone：	+86 28 85423998
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：	wujiaxuan0816@126.com	研究负责人电子邮件： Study leader's E-mail：	weimin003@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：	中国四川省成都市武侯区国学巷37号	研究负责人通讯地址：	中国四川省成都市武侯区国学巷37号
Applicant address：	37 Guoxue Alley, Wuhou District, Chengdu, Sichuan, China	Study leader's address：	37 Guoxue Alley, 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
研究负责人所在单位：	四川大学华西医院
Affiliation of the Leader：	West China Hospital of 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：	2024年审（1762）号	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审查委员会
Name of the ethic committee：	Ethics Committee on Biomedical Research West China Hospital of Sichuan University
伦理委员会批准日期： Date of approved by ethic committee：	2024-09-10 00:00:00
伦理委员会联系人：	李娜
Contact Name of the ethic committee：	Li Na
伦理委员会联系地址：	中国四川省成都市武侯区国学巷37号
Contact Address of the ethic committee：	37 Guoxue Alley, Wuhou District, Chengdu, Sichuan, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 28 85422654	伦理委员会联系人邮箱： Contact email of the ethic committee：	188974152@qq.com

研究实施负责（组长）单位：

四川大学华西医院

Primary sponsor：

West China Hospital of Sichuan University

研究实施负责（组长）单位地址：

中国四川省成都市武侯区国学巷37号

Primary sponsor's address：

37 Guoxue Alley, 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	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	四川大学华西医院	具体地址：	中国四川省成都市武侯区国学巷37号
Institution hospital：	West China Hospital of Sichuan University	Address：	37 Guoxue Alley, Wuhou District, Chengdu, Sichuan, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

慢阻肺

Target disease：

COPD

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

队列研究

Study design：

Cohort study

研究目的：

本研究旨在针对我国西部地区慢性呼吸系统疾病发病率高、诊疗水平不均衡等问题，通过大规模人群队列与多中心研究，系统揭示疾病的流行特征及关键风险因素，构建适用于不同地域和民族人群的早期筛查与风险评估模型；结合多组学技术与人工智能方法，实现慢阻肺、肺癌及相关疾病的精准分型与个体化诊疗；同时研发前沿检测与诊疗技术，建立基于信息化平台的分级协同防控体系，从而提升呼吸慢病的早筛、早诊和规范化治疗水平，降低疾病致残率和死亡率。

Objectives of Study：

This study aims to address issues such as the high incidence of chronic respiratory diseases and uneven diagnosis and treatment levels in western China. Through large-scale population cohorts and multi-center studies, it systematically reveals the epidemiological characteristics and key risk factors of these diseases, and constructs early screening and risk assessment models applicable to populations of different regions and ethnicities. By integrating multi-omics technologies and artificial intelligence methods, it achieves precise classification and individualized diagnosis and treatment for COPD, lung cancer, and related diseases. At the same time, it develops cutting-edge detection and treatment technologies and establishes a hierarchical, collaborative prevention and control system based on an information platform, thereby improving early screening, early diagnosis, and standardized treatment levels for chronic respiratory diseases, and reducing disease-related disability and mortality.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Age >=18 years at enrollment: Setting 18 years as the lower age limit for enrollment is not based on the age characteristics of COPD/pulmonary nodule onset, but rather combines the current status of risk factor exposure in western Chinese community populations (such as youth smoking and early-life exposure to biomass fuels) with public health needs for early prevention and treatment of diseases. This approach includes participants from the disease prevention stage, aligning with the core strategy of this study: "early prevention, early screening, early diagnosis, and early treatment." Meanwhile, 18 years is the legal age of adulthood in China, ensuring that participants have independent capacity for informed consent, thereby safeguarding research ethics and the autonomy of evaluation data.

2. Registered residents of the study community who have resided continuously in the community for at least 6 months: The requirement of being "registered and residing for >=6 months" ensures that study subjects are permanent community residents, consistent with the service population of community health service centers. This aligns with the practical scenario of community chronic disease management, truly reflecting the prevalence and management needs of chronic respiratory diseases in the community. Furthermore, stable residency provides a foundation for long-term follow-up (up to 18 months), preventing loss to follow-up due to participant mobility and ensuring the completeness of treatment effect evaluation and outcome indicator monitoring.

3. Voluntary participation in all study activities, including screening, diagnosis, treatment, and follow-up, with signed written informed consent: Voluntary signing of informed consent is a core prerequisite for protecting participants' rights. Through a structured, step-by-step informed consent process, the study clearly explains the research content, potential risks, and benefits to participants, allowing them to make autonomous choices based on full understanding. This approach avoids safety and ethical risks associated with involuntary participation from the outset.

4. Possession of normal comprehension and communication abilities, capable of independently or with assistance completing study-related scales such as the West China COPD Screening Questionnaire and quality of life assessments: Scale completion ability: The core evaluation indicators of this study (such as disease awareness rate, CAT/mMRC scores, and medication adherence) are all collected through questionnaires/scales. Participants are required to have the corresponding comprehension and completion abilities to ensure the authenticity and accuracy of evaluation data, avoiding bias that could affect the reliability of study results. Additionally, this requirement matches the practical operational capabilities of community COPD screening, ensuring the smooth implementation of screening and evaluation work.

排除标准：

1. 疾病终末期，经临床评估预期生存期＜6 个月：终末期患者的核心医疗需求为姑息治疗，而非呼吸慢病的早筛早治与规范化管理，纳入此类患者会偏离本研究目标；同时，终末期患者的身体状况差，相关临床指标（如肺功能、生活质量）受基础疾病影响大，易导致评价偏倚。 2. 存在严重认知功能障碍、精神疾病或沟通障碍，无法配合完成筛查、治疗及随访：此类患者无法配合完成问卷填写、CT筛查、肺功能检查、吸入装置使用培训等研究核心操作，既无法获得准确的诊断与评价数据，也无法接受规范化的呼吸慢病治疗与管理， 3. 计划在 12 个月内迁出本研究社区，无法完成研究规定的随访流程：高流动度人群会增加研究失访风险，同时不符合预设社区管理场景 4. 近3个月患心肌梗死、脑卒中、休克：肺功能检查过程可能有诱发上述患者疾病，导致不良结局 5. 近 4 周严重心功能不全、心律失常、不稳定性心绞痛、未控制的高血压病、主动脉瘤：肺功能检查过程可能有诱发上述患者疾病，导致不良结局 6. 近 4 周大咯血、气胸、巨大肺大疱且不准备手术治疗者：肺功能检查过程可能有诱发上述患者进一步大咯血、肺大泡破裂致气胸，导致不良结局 7. 无法停氧、最大屏气时间低于7秒的受试者：肺功能检查过程的必要条件 8. 正在参与研究性药品 (IMP) 的临床试验，或在3个月内或IMP的 5.5个半衰期内：上述患者可能存在混杂呼出气成分，影响呼出气成分检测 9. 孕妇：属于CT检查禁忌。

Exclusion criteria：

1. End-stage disease with a clinically assessed life expectancy of <6 months: The core medical need for end-stage patients is palliative care, rather than early screening, early treatment, and standardized management of chronic respiratory diseases. Including such patients would deviate from the objectives of this study. Furthermore, end-stage patients have poor physical conditions, and their relevant clinical indicators (such as lung function and quality of life) are significantly influenced by underlying diseases, which may lead to evaluation bias. 2. Presence of severe cognitive impairment, mental illness, or communication barriers that prevent cooperation with screening, treatment, and follow-up: Such patients cannot cooperate with core study procedures, including questionnaire completion, CT screening, pulmonary function tests, and training on the use of inhalation devices. Consequently, accurate diagnostic and evaluation data cannot be obtained, nor can they receive standardized treatment and management for chronic respiratory diseases. 3. Plan to move out of the study community within 12 months, making it impossible to complete the follow-up process required by the study: High mobility increases the risk of loss to follow-up and does not align with the predefined community management scenario. 4. Myocardial infarction, stroke, or shock within the past 3 months: The pulmonary function test procedure may induce exacerbation of these conditions in such patients, leading to adverse outcomes. 5. Severe cardiac insufficiency, arrhythmia, unstable angina, uncontrolled hypertension, or aortic aneurysm within the past 4 weeks: The pulmonary function test procedure may induce exacerbation of these conditions in such patients, leading to adverse outcomes. 6. Massive hemoptysis, pneumothorax, or giant pulmonary bullae without planned surgical treatment within the past 4 weeks: The pulmonary function test procedure may induce further massive hemoptysis or rupture of pulmonary bullae leading to pneumothorax in such patients, resulting in adverse outcomes. 7. Subjects who cannot discontinue oxygen therapy or have a maximum breath-holding time of less than 7 seconds: These are necessary conditions for conducting pulmonary function tests. 8. Currently participating in a clinical trial of investigational medicinal products (IMP), or within 3 months or 5.5 half-lives of IMP administration: Such patients may have confounding factors in exhaled breath components, affecting the detection of exhaled breath constituents. 9. Pregnant women: Contraindicated for CT examination.

研究实施时间：

Study execute time：

从 From 2024-08-01 00:00:00至 To 2028-07-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-06-19 00:00:00 至 To 2028-07-31 00:00:00

干预措施：

Interventions：

组别：	观察组	样本量：	200000
Group：	Observational group	Sample size：	200000
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

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)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	四川大学华西医院	单位级别：	三级甲等
Institution hospital：	West China Hospital of Sichuan University	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	四川	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	攀枝花市中心医院	单位级别：	三级甲等
Institution hospital：	Panzhihua Central Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	四川	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	川北医学院附属医院	单位级别：	三级甲等
Institution hospital：	Affiliated Hospital of North Sichuan Medical College	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	四川	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	四川大学华西医院	单位级别：	三级甲等
Institution hospital：	Sichuan University West China Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	流行病学与临床基本指标	指标类型：	主要指标
Outcome：	Epidemiology and Basic Clinical Indicators	Type：	Primary indicator
测量时间点：	2028.07	测量方法：	1.标准化问卷调查；2.电子病历及体检数据收集
Measure time point of outcome：	2028.07	Measure method：	1. Standardized questionnaire survey; 2. Collection of electronic medical records and physical examination data

指标中文名：	影像学指标	指标类型：	主要指标
Outcome：	Imaging indicators	Type：	Primary indicator
测量时间点：	2028.07	测量方法：	1.低剂量螺旋CT检查 2.CT三维重建技术 3.人工智能影像分析系统（影像组学）
Measure time point of outcome：	2028.07	Measure method：	1. Low-dose spiral CT examination 2. CT three-dimensional reconstruction technology 3. Artificial intelligence imaging analysis system (radiomics)

指标中文名：	生物标志物指标	指标类型：	次要指标
Outcome：	Biomarker indicators	Type：	Secondary indicator
测量时间点：	2028.07	测量方法：	1.呼气检测技术（VOC检测）
Measure time point of outcome：	2028.07	Measure method：	1. Exhalation detection technology (VOC detection)

指标中文名：	环境与暴露因素指标	指标类型：	主要指标
Outcome：	Environmental and Exposure Factor Indicators	Type：	Primary indicator
测量时间点：	2028.07	测量方法：	1.问卷调查获取暴露史 2.环境监测数据匹配（区域空气质量数据）
Measure time point of outcome：	2028.07	Measure method：	1. Obtain exposure history through questionnaire surveys 2. Match environmental monitoring data (regional air quality data)

指标中文名：	遗传与分子生物学指标	指标类型：	主要指标
Outcome：	Genetic and Molecular Biology Indicators	Type：	Primary indicator
测量时间点：	2028.07	测量方法：	1.全基因组测序（WGS） 2.多组学技术（基因组学、转录组学等） 3.生物信息学分析与功能实验
Measure time point of outcome：	2028.07	Measure method：	1. Whole Genome Sequencing (WGS) 2. Multi-omics technologies (genomics, transcriptomics, etc.) 3. Bioinformatics analysis and functional experiments

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血液	组织：
Sample Name：	Serum	Tissue：
人体标本去向	使用后保存	说明
Fate of sample：	Preservation after use	Note：

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：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	NA	岁 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

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	无
Blinding：	None

是否共享原始数据： IPD sharing	是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）：	研究结束后半年；国家生物信息中心(https://www.cncb.ac.cn/)
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Six months after the completion of the research; China National Center for Bioinformation (https://www.cncb.ac.cn/)
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(Case Record Form,CRF)，电子采集和管理系统(Electronic Data Capture,EDC)
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form,CRF,Electronic Data Capture,EDC
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-06-17 11:41:02