Impact of Airway Mucus Plugs on Secondary Pulmonary Fibrosis in COPD Patients: A Single-Center Case-Control Study
NCT ID: NCT07236541
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2025-10-30
2026-06-30
Brief Summary
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During surgery, distal non-tumorous lung tissues and airway mucus will be collected for histological and molecular analyses. Mucus plug burden will be quantified using AB-PAS staining, and fibrosis will be assessed using Masson staining. Expression of epithelial-mesenchymal transition (EMT) markers, fibrotic markers, and the mechanosensitive ion channel Piezo1 will also be measured. COPD patients (FEV₁/FVC \<0.70) will be compared with non-COPD surgical controls.
The study aims to clarify whether mucus plugs are associated with increased fibrosis and to explore the potential involvement of mechanical-signaling pathways, including Piezo1 activation. Findings may provide new clinical and pathological evidence for mucus-induced fibrotic remodeling in COPD and help identify novel therapeutic targets.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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COPD（chronic hypoxia）
No intervention; observational biospecimen collection only
No intervention; observational biospecimen collection only
Normal（Normoxia）
No intervention; observational biospecimen collection only
No intervention; observational biospecimen collection only
Interventions
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No intervention; observational biospecimen collection only
No intervention; observational biospecimen collection only
Eligibility Criteria
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Inclusion Criteria
* Planned radical resection for lung cancer, with postoperative pathological diagnosis of primary lung cancer;
* During surgery, non tumor lung tissue at a distance of ≥ 5 cm from the tumor edge can be obtained; ④ Case group: Preoperative pulmonary function examination confirmed diagnosis of COPD (FEV ₁/FVC\<0.70); ⑤ Control group: Preoperative lung function was normal (FEV ₁/FVC ≥ 0.70), with no history of COPD; ⑥ The subjects are able to understand and sign the informed consent form
Exclusion Criteria
* Active pulmonary infections (such as bacterial pneumonia, fungal infections, active tuberculosis);
* Having received neoadjuvant radiotherapy or chemotherapy, which may affect the morphology or molecular results of distal lung tissue; ④ Combined severe immunodeficiency or long-term systemic immunosuppressive therapy (such as glucocorticoids ≥ 20 mg/d, More than 4 weeks);
* Merge with other serious systemic diseases (such as advanced heart failure, end-stage renal disease), affecting study compliance or Survival expectation; ⑥ Pregnant or lactating women; ⑦ Refusing to sign the informed consent form or deemed unsuitable by the researcher to participate in the study.
18 Years
89 Years
ALL
No
Sponsors
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Ming Zhong
OTHER
Responsible Party
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Ming Zhong
Chief Physician and Professor, Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital, Fudan University
Locations
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Zhongshan hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B2025-657
Identifier Type: -
Identifier Source: org_study_id
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