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

Recruiting now · Not applicable

Conditions studied: Lung Cancer (Diagnosis)

In brief

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 facts

Study ID

NCT07552584

Run by

Vejle Hospital

People needed

1000

Starts

2026-05-26

Expected to finish

2034-04-01

Last updated by the study team

2026-06-03

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with COPD.
• => 50 years.
• Former or current smoker.
• Speaks and understands Danish.
• Able to give informed consent to participation.

You may not qualify if…

• Had a CT scan of the thorax within 6 months.
• Received active treatment for cancer within one year (except non-melanoma skin cancer and carcinoma in situ cervicis uteri).
• Diagnosed with cancer within one year (except non-melanoma skin cancer and carcinoma in situ cervicis uteri).
• Presents with symptoms giving suspicion of cancer (except non-melanoma skin cancer and carcinoma in situ cervicis uteri).
• In a condition not allowing diagnostic workup for or treatment of lung cancer.
• Does not have Eboks (electronic communication with Danish authorities).

Where it is running

• Lillebaelt Hospital Vejle, University Hospital of Southern Denmark — Vejle, Denmark (enrolling)
• General practices, Vejle area — Vejle, Denmark (enrolling)

Full record on ClinicalTrials.gov

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