NCT07552584

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
96mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Apr 2034

Study Start

First participant enrolled

April 1, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2034

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 20, 2026

Last Update Submit

April 29, 2026

Conditions

Lung Cancer (Diagnosis)

Keywords

Lung cancerBiomarkersMachine learningRisk stratificationCOPD

Outcome Measures

Primary Outcomes (1)

  • The fraction of patients consenting to participate in the study.

    The fraction of patients consenting to participate in the study.

    2 years

Secondary Outcomes (14)

  • Number of low-dose CT scans performed

    2 years

  • Number of correctly identified lung cancer cases

    Up to 8 years

  • Number of lung cancer cases

    Up to 8 years

  • Stage distribution of lung cancer cases

    Up to 8 years

  • Number of patients with incidental findings on low-dose CT

    2 years

  • +9 more secondary outcomes

Other Outcomes (1)

  • Qualitative analysis of interview data

    3 years.

Study Arms (1)

Risk stratification

EXPERIMENTAL

Risk stratification for lung cancer using standard blood tests, machine learning and a DNA methylation analysis.

Other: Risk stratification

Interventions

Risk stratificationOTHER

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.

Risk stratification

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lillebaelt Hospital Vejle, University Hospital of Southern Denmark

Vejle, 7100, Denmark

RECRUITING

General practices, Vejle area

Vejle, Denmark

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsDiseasePulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveChronic DiseaseDisease Attributes

Study Officials

  • Ole Hilberg, MD, DMSc

    Department of Medicine, Lillebaelt Hospital Vejle, University Hospital of Southern Denmark

    STUDY CHAIR

  • Sara Witting Christensen Wen, MD, PhD

    Department of Biochemistry and Immunology, Lillebaelt Hospital Vejle, University Hospital of Southern Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Witting Christensen WC Wen, MD, PhD

CONTACT

+45 79406511sara.witting.christensen.wen@rsyd.dk

Lene Horsted, Study nurse

CONTACT

+45 79409946breathe@rsyd.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2034

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)