Overview
The goal of the interventional study is to evaluate whether risk-based stratification using the PLCOm2012 model and a machine learning (ML) model can identify patients with chronic obstructive pulmonary disease (COPD) who are at high risk of developing lung cancer and may benefit from low-dose computed tomography (LDCT) screening. The study population includes adults aged 50 years and older with COPD and a history of smoking attending an outpatient clinic.
The main question it aims to answer are:
\- What is the incidence of histopathologically confirmed lung cancer following risk-based stratification?
Participants will:
- Undergo lung cancer risk assessment using the PLCOm2012 model and an ML-based model based on clinical and laboratory data
- Be referred for LDCT if classified as high-risk
- Continue standard care if classified as low-risk
- Be followed through electronic health records for up to six years to assess outcomes including lung cancer incidence, adherence to LDCT, time to imaging, healthcare utilization, costs, and safety
Description
Lung cancer is a leading cause of cancer-related mortality in Denmark, largely due to late-stage diagnosis. Early detection through low-dose computed tomography (LDCT) has been shown to reduce mortality in trials such as the National Lung Screening Trial and the NELSON trial, but implementation remains limited due to cost, capacity, and risk of false-positive findings. Risk-based approaches may improve screening efficiency by identifying individuals at highest risk.
This prospective, single-centre interventional study evaluates the feasibility and clinical implementation of lung cancer risk stratification in patients with chronic obstructive pulmonary disease (COPD). A total of 1,000 patients will be enrolled from an outpatient clinic. At baseline, participants will undergo risk assessment using the PLCOm2012 model and a machine learning (ML)-based model based on clinical and laboratory data.
Patients identified as high-risk by either model will be referred for LDCT, while low-risk patients will continue standard care. If LDCT findings are suspicious, further diagnostic evaluation will be performed according to routine clinical practice. Participants will be followed through electronic health records for up to six years, with outcome assessment at 1, 2, and 6 years.
The primary outcome is the incidence of histopathologically confirmed lung cancer. Secondary outcomes include adherence to LDCT referral, time from risk assessment to LDCT, number needed to screen, healthcare utilization, healthcare costs, and safety, including adverse events related to diagnostic procedures.
Eligibility
Inclusion Criteria:
- Diagnosed with COPD
- Age ≥ 50 years
- Attendance at the outpatient Respiratory Medicine clinic, Vejle Hospital, University Hospital of Southern Denmark
- Smoking history (current or former smoker)
- Consent to translational research and biobank.
Exclusion Criteria:
- Previous diagnosis of lung cancer within the last five years.
- Active treatment for cancer within the last 12 months except non-melanoma skin cancer and carcinoma in situ cervicis uteri.
- Invasive methods to verify potential lung cancer not an option.
- Inability to provide informed consent.
