Blood Based Risk Evaluation With AI for Targeted Primary Health Care in Early Lung Cancer Detection

The study is a prospective, non-randomized feasibility study evaluating blood sample and machine learning-based risk stratification for lung cancer in patients with COPD (chronic obstructive pulmonary disease). Patients with COPD will be recruited in general practice, where they will have a blood sample drawn. All data will be analyzed by the machine learning model, and patients with increased risk of lung cancer will be referred for a low-dose CT scan of the chest. The primary objective of the study is to evaluate the feasibility of AI and DNA methylation-based risk stratification for lung cancer in patients with COPD in a primary care setting. The secondary objectives are to evaluate the safety of the risk stratification approach, the potential effects on quality of life and wellbeing, to gain insight into the patient and physician perspectives, and to estimate the health economic consequences.

NCT Number	NCT07552584
Lead Sponsor	Vejle Hospital
Conditions	Lung Cancer (Diagnosis)
Enrollment	1,000 participants
Start Date	2026-05-26
Primary Completion	2028-04 (estimated)
Study Completion	2034-04 (estimated)
Updated on ClinicalTrials.gov	2026-06-03