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Research on Precise Classification and Advanced Diagnosis and Treatment Technologies for Chronic Respiratory Diseases with Regional and Multi-Ethnic Characteristics

Research on Precise Classification and Advanced Diagnosis and Treatment Technologies for Chronic Respiratory Diseases with Regional and Multi-Ethnic Characteristics

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126851
Enrollment
Unknown
Registered
2026-06-17
Start date
2025-06-19
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Interventions

Observational group:None

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Epidemiology and Basic Clinical Indicators;Imaging indicators;Environmental and Exposure Factor Indicators;Genetic and Molecular Biology Indicators;

Secondary

MeasureTime frame
Biomarker indicators;

Countries

China

Contacts

Public ContactLi Weimin

West China Hospital of Sichuan University

weimin003@163.com+86 28 85423998

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026