Early Detection of Lung Cancer With Machine Learning Based on Routine Clinical Investigations

Study Overview
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Brief Summary
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This observational, cross-sectional study in lung cancer patients and lung cancer-free controls aims to develop a machine learning model for early detection of LC based on routine, widely accessible and minimally invasive clinical investigations. The model with adequate predictive performance could later be used in clinical practice as an aid in defining the optimal population and timing for lung cancer screening program.

Official Title
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Early Detection of Lung Cancer With Machine Learning Based on Routine Clinical Investigations

Conditions
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Adenocarcinoma of Lung; Bronchial Neoplasms; Early Detection of Cancer; Machine Learning

Intervention / Treatment
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* Other: Observational


Participation Criteria
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Eligibility Criteria
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All patients: Age ≥ 50 years and < 80 years at the index date of diagnosis (for Cases) or pseudodiagnosis (for Controls). Presence of at least one extended blood analysis, spirometry and DLCO report within the 6 months before the index date. Chest CT scan performed in a non-urgent setting (electively) within the 6 months before the index date (= index CT). Active smokers at the index date or former smokers that ceased smoking within 15 years before the index date. Smoking history ≥ 20 pack-years. Additional for Cases only: Confirmed histological diagnosis of bronchogenic lung cancer in the time period ≥ 2010 and ≤ 2020. Additional for Controls only: Absence of lung cancer at all times ≤ 2020, confirmed by chest CT scan at the index date. Documented to live without diagnosis of lung cancer for at least 3 years after the index date. Extended criteria for the lung cancer prediction subgroup: In addition to the above stated inclusion criteria, patients in this subgroup have at least one extended blood analysis, spirometry and DLCO report available in the time interval between 3-5 years before the index date.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Disease cohort<br>Observational, no interventions | Other: Observational<br>* No interventions.<br>|
| Control cohort<br>Observational, no interventions | Other: Observational<br>* No interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop a model with high predictive performance for early detection of non-small cell lung cancer (NSCLC) in the eligible patient population. | The primary outcome is tested by calculating a joint rectangular 95% confidence region for {sensitivity, specificity} and compared with the reported accuracy of NLST study screening criteria. | 11 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate that the newly developed model achieves higher prediction accuracy than the well-validated model PLCOm2012. |  | 11 years |