Actively Recruiting
Blood Based Risk Evaluation With AI for Targeted Primary Health Care in Early Lung Cancer Detection
Led by Vejle Hospital · Updated on 2026-06-03
1000
Participants Needed
2
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the feasibility of using blood samples combined with machine learning to assess lung cancer risk in patients with chronic obstructive pulmonary disease (COPD) in a primary care setting. People with COPD are at higher risk for lung cancer, and the study explores a personalized approach using AI and DNA methylation markers to improve early detection. The goal is to see if this risk stratification can be safely and effectively done within routine general practice care. Participants with COPD, aged 50 or older, will have blood samples taken at their general practice. These samples will be analyzed using a machine learning model and DNA methylation testing to predict lung cancer risk. Those identified as higher risk will be referred for a low-dose CT scan of the chest. Current smokers at risk will also be referred to a smoking cessation program. This study includes a two-year evaluation period and will monitor the number of CT scans, lung cancer diagnoses, and smoking cessation initiations. During the study, patients will provide clinical data through an online database and undergo blood collection at their clinic. Researchers will track participation rates, adherence to the protocol, safety outcomes, quality of life, well-being, and economic impacts over up to eight years. Patient and physician perspectives will also be gathered to understand the experience of this approach. The primary outcome is the fraction of patients agreeing to participate within two years.
CONDITIONS
Brief Title
Blood Based Risk Evaluation With AI for Targeted Primary Health Care in Early Lung Cancer Detection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with chronic obstructive pulmonary disease (COPD)
- Age 50 years or older
- Current or former smoker
- Speaks and understands Danish
- Able to provide informed consent to participate
You will not qualify if you...
- Had a CT scan of the chest within the past 6 months
- Received active cancer treatment within the past year (except non-melanoma skin cancer and carcinoma in situ cervicis uteri)
- Diagnosed with cancer within the past year (except non-melanoma skin cancer and carcinoma in situ cervicis uteri)
- Has symptoms that suggest cancer (except non-melanoma skin cancer and carcinoma in situ cervicis uteri)
- In a medical condition that prevents diagnostic workup or treatment for lung cancer
- Does not have access to Eboks (electronic communication with Danish authorities)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial assessment with ongoing follow-up as determined by clinical care
Participants with COPD have their risk of lung cancer evaluated using a machine learning model incorporating clinical data, standard blood tests, and DNA methylation analysis. Participants at increased risk may be referred for a low-dose CT scan and current smokers may be referred to a smoking cessation program.
1 visit for blood sample collection; additional visits if referred for low-dose CT or smoking cessation
Duration - Up to 8 years
Participants are monitored for lung cancer outcomes, adherence, and health status over time following risk stratification.
Follow-up visits as per clinical care and study protocol
Trial Site Locations
Total: 2 locations
1
Lillebaelt Hospital Vejle, University Hospital of Southern Denmark
Vejle, Denmark, 7100
Actively Recruiting
2
General practices, Vejle area
Vejle, Denmark
Actively Recruiting
Research Team
S
Sara Witting Christensen WC Wen, MD, PhD
L
Lene Horsted, Study nurse
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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