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NCT07848815
Risk-Based Lung Cancer Detection in COPD Patients
Conditions: Lung Cancer (Diagnosis), COPD (Chronic Obstructive Pulmonary Disease)
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1000
Sponsor: Vejle Hospital
Location: Vejle Hospital, University Hospital of Southern Denmark Vejle Region Syddanmark
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 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.
Source: ClinicalTrials.gov (NCT07848815). StuddyBuddy aggregates publicly available trial information.