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

NCT07552584 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-06-03

No results posted yet for this study

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.

Conditions

  • Lung Cancer (Diagnosis)

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.

Sponsors & Collaborators

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Ole Hilberg, MD, DMSc · Department of Medicine, Lillebaelt Hospital Vejle, University Hospital of Southern Denmark

  • Sara Witting Christensen Wen, MD, PhD · Department of Biochemistry and Immunology, Lillebaelt Hospital Vejle, University Hospital of Southern Denmark

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-26
Primary Completion
2028-04-30
Completion
2034-04-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07552584 on ClinicalTrials.gov