Do airway mucus plugs cause lung scarring in people with COPD undergoing lung cancer surgery

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

This study will see if airway mucus plugs in people with COPD are linked to lung scarring by analyzing lung tissue and mucus collected during lung cancer operations.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years to 89 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT07236541 on ClinicalTrials.gov

What this trial studies

This is a single-center prospective case-control study comparing COPD patients (FEV1/FVC <0.70) to surgical controls with normal spirometry who are undergoing radical lung cancer resection. During surgery investigators will collect distal non-tumorous lung tissue and airway mucus for histological and molecular analysis. Mucus plug burden will be quantified with AB-PAS staining and fibrosis with Masson staining, while expression of EMT markers, fibrotic markers, and the mechanosensitive channel Piezo1 will be measured. The study involves only biospecimen collection and laboratory analyses, with no interventional treatment.

Who should consider this trial

Good fit: Adults (≥18) scheduled for radical lung cancer surgery who can provide non-tumorous lung tissue and airway mucus during the operation, including COPD patients (FEV1/FVC <0.70) and surgical controls with normal lung function.

Not a fit: Patients not having lung cancer surgery, those with pre-existing interstitial lung disease or active pulmonary infection, those who received neoadjuvant chemo/radiotherapy, minors, or anyone unable to give informed consent are unlikely to benefit from participation.

Why it matters

Potential benefit: If a link is found, preventing or clearing mucus plugs could become a strategy to reduce or slow secondary lung scarring in COPD.

How similar studies have performed: Previous work has linked mucus plugs to airflow obstruction and worse outcomes, but direct evidence that mucus plugs drive secondary fibrosis in COPD surgical specimens is limited, so this approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where this trial is running

Shanghai

• Zhongshan hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: shengyu hao

Conditions Lung Fibrosis