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RECRUITING Not applicable ClinicalTrials.gov

Risk-Based Lung Cancer Detection in COPD Patients

Sponsor: Vejle Hospital • ClinicalTrials.gov ID: NCT07848815

Registry updated: 2026-09-30
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Description

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

Interventions

  • Risk-based prediction models (Other)
    Patients will be stratified into high-risk and low-risk groups using both the Lung Cancer Risk Prediction Calculator for smokers (PLCOm2012) and an in-house developed machine learning model based on sex, age, smoking status, and laboratory data from routine blood sample analyses.

Eligibility criteria

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.

Conditions

Lung Cancer (Diagnosis) COPD (Chronic Obstructive Pulmonary Disease)

Locations

  • Vejle Hospital, University Hospital of Southern Denmark — Vejle, Region Syddanmark, Denmark
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record