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

Study acronym: BREATHE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Start date changed from estimate of Apr 2026 to May 26, 2026v3
  2. Notable Primary endpoint(s) modified
    • Secondary endpoints: details revised at 4 of 14 entries
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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 Details
NCT Number NCT07552584
Lead Sponsor Vejle Hospital
Conditions
(from sponsor)
Lung Cancer (Diagnosis)
Related terms Disease, Lung Neoplasms, Pulmonary Disease, Chronic Obstructive
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov