Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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Early Lung Cancer Detection in High-Risk Patients With Risk-Based Machine Learning Models and Biomarkers

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Vejle Hospital, University Hospital of Southern Denmark
RECRUITING
Vejle
Contact Information
Primary
Cecilie M. Jacobsen, MScEng
cecilie.mondrup.jacobsen@rsyd.dk
+4579406644
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2033-12
Participants
Target number of participants: 1000
Treatments
Experimental: COPD patients undergoing lung cancer risk assessment
All enrolled patients with chronic obstructive pulmonary disease (COPD) will undergo lung cancer risk assessment using the PLCOm2012 model and an in-house developed machine learning model. Based on the model-derived risk score, patients will be stratified into high-risk and low-risk groups. Patients classified as high-risk will undergo further diagnostic evaluation for lung cancer according to the study protocol. Patients classified as low-risk will continue with standard of care management. Outcomes will be compared between risk groups to evaluate the feasibility and clinical utility of the model.
Sponsors
Leads: Vejle Hospital

This content was sourced from clinicaltrials.gov