Blood test and AI to find people with COPD at higher risk of lung cancer
Blood Based Risk Evaluation With AI for Targeted Primary Health Care in Early Lung Cancer Detection
This project will see if a blood test combined with an AI model can identify people with COPD who are at higher risk of lung cancer so they can be referred for a low‑dose CT scan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Vejle Hospital Academic / other |
| Locations | 2 sites (Vejle and 1 other locations) |
| Trial ID | NCT07552584 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-randomized feasibility project enrolling about 1,000 patients with COPD from general practices in the Vejle area. Participants give a blood sample that is analyzed for DNA methylation markers (including AHRR) and processed by a machine learning model using clinical and routine lab data. Those classified at increased risk are referred for a low‑dose CT scan of the chest. The primary aim is to test feasibility of this workflow in primary care, with secondary aims addressing safety, effects on quality of life and wellbeing, stakeholder perspectives, and preliminary health economic impact.
Who should consider this trial
Good fit: Ideal participants are people aged 50 or older with diagnosed COPD who are current or former smokers, speak Danish, and can give informed consent.
Not a fit: Those unlikely to benefit include people without COPD, under 50 or never‑smokers, individuals who had a recent thoracic CT, people with recent or active cancer or with current symptoms suspicious for cancer, and those unable to undergo diagnostic workup or without Eboks.
Why it matters
Potential benefit: If successful, the approach could detect lung cancer earlier and concentrate CT resources on people most likely to benefit, reducing unnecessary imaging.
How similar studies have performed: Low‑dose CT screening has been shown to reduce lung cancer mortality, and preliminary studies of methylation markers and AI risk models have shown promise but are still early and not yet widely implemented.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with COPD. * =\> 50 years. * Former or current smoker. * Speaks and understands Danish. * Able to give informed consent to participation. Exclusion Criteria: * 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 this trial is running
Vejle and 1 other locations
- Lillebaelt Hospital Vejle, University Hospital of Southern Denmark — Vejle, Denmark (Recruiting)
- General practices, Vejle area — Vejle, Denmark (Recruiting)
Study contacts
- Principal investigator: Sara Witting Christensen Wen, MD, PhD — Department of Biochemistry and Immunology, Lillebaelt Hospital Vejle, University Hospital of Southern Denmark
- Study coordinator: Sara Witting Christensen WC Wen, MD, PhD
- Email: sara.witting.christensen.wen@rsyd.dk
- Phone: +45 79406511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.