Actively Recruiting

Age: 18Years - 89Years
All Genders
NCT07236541

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

Led by Ming Zhong · Updated on 2025-11-19

20

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Planned radical lung cancer surgery with postoperative diagnosis of primary lung cancer
  • Ability to obtain non-tumor lung tissue at least 5 cm away from tumor edge during surgery
  • For case group: confirmed COPD diagnosis with preoperative lung function showing FEV1/FVC less than 0.70
  • For control group: normal preoperative lung function with FEV1/FVC 0.70 or higher and no history of COPD
  • Ability to understand and sign the informed consent form
Not Eligible

You will not qualify if you...

  • Presence of other interstitial lung diseases or idiopathic pulmonary fibrosis before or during surgery
  • Lung fibrosis caused by pneumoconiosis or tuberculosis
  • Active lung infections such as bacterial pneumonia, fungal infections, or active tuberculosis
  • Prior neoadjuvant radiotherapy or chemotherapy affecting lung tissue
  • Severe immunodeficiency or long-term systemic immunosuppressive therapy (e.g., glucocorticoids 20 mg/day or more for over 4 weeks)
  • Serious systemic diseases affecting study participation or survival (e.g., advanced heart failure, end-stage kidney disease)
  • Pregnancy or breastfeeding
  • Refusal to sign informed consent or deemed unsuitable by the researcher

AI-Screening

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Trial Site Locations

Total: 1 location

1

Zhongshan hospital

Shanghai, China, 200433

Actively Recruiting

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Research Team

S

shengyu hao

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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