Impact of Airway Mucus Plugs on Secondary Pulmonary Fibrosis in COPD Patients: A Single-Center Case-Control Study

Обзор

Chronic obstructive pulmonary disease (COPD) is frequently accompanied by airway mucus plugs, which are closely associated with airflow obstruction, acute exacerbations, and increased mortality. However, whether mucus plugs contribute to secondary pulmonary fibrosis remains unclear. This single-center, prospective, case-control study aims to investigate the relationship between airway mucus plugs and lung fibrosis in patients with COPD undergoing lung cancer surgery. 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.

Вмешательства

• Другое No intervention; observational biospecimen collection only
  No intervention; observational biospecimen collection only

Первичные конечные точки

• Clarify the relationship between airway mucus embolism and secondary pulmonary fibrosis in COPD patients [Срок оценки: At the time of surgery and within 6 months after sample collection for laboratory analysis]

Вторичные конечные точки (1)

• The correlation between mucus plugs and clinical features [Срок оценки: At the time of surgery and within 6 months after sample collection for laboratory analysis]

Критерии участия

Критерии включения

• ① Age ≥ 18 years old;

• 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

Критерии исключения

• ① Clear presence of other interstitial lung diseases (ILD) or idiopathic pulmonary fibrosis before or during surgery （IPF）、 Fibrosis after pneumoconiosis or tuberculosis;

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Китай · 1 центр

• Zhongshan hospital — Шанхай

Идентификаторы

NCT: NCT07236541 · B2025-657

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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