Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
ID07552584

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

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Risk Stratification

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

Long-term Monitoring

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

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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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Frequently Asked Questions

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