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RECRUITING
NCT07552584
NA

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

Sponsor: Vejle Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2026-04

Completion Date

2034-04

Last Updated

2026-04-27

Healthy Volunteers

No

Interventions

OTHER

Risk stratification

Patients with COPD will have their risk of lung cancer evaluated using a machine learning model incorporating clinical data and standard blood tests as well as a DNA methylation biomarker. If the risk of lung cancer is above the cut-off, the patient will be referred for a low-dose CT scan of the chest. Currently smoking patients will be referred for a smoking cessation program.

Locations (2)

Lillebaelt Hospital Vejle, University Hospital of Southern Denmark

Vejle, Denmark

General practices, Vejle area

Vejle, Denmark