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| Name | Class |
|---|---|
| Jozef Stefan Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disease cohort | Observational, no interventions |
| |
| Control cohort | Observational, no interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | No interventions. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate that the newly developed model achieves higher prediction accuracy than the well-validated model PLCOm2012. | 11 years |
| Measure | Description | Time Frame |
|---|---|---|
| Develop a model with high predictive performance for early detection of small cell lung cancer (SCLC) in the eligible patient population. | 11 years | |
| Develop a model for prediction of lung cancer in a time period when the disease is still highly unlikely to be clinically detectable, in a subset of patients who meet the extended eligibility criteria. |
All patients:
Additional for Cases only: Confirmed histological diagnosis of bronchogenic lung cancer in the time period ≥ 2010 and ≤ 2020.
Additional for Controls only:
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.
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The study will include adult active or former smokers who are at high-risk of developing lung cancer, and would be considered suitable candidates for lung cancer screening. The study will focus on patients with confirmed bronchogenic lung cancer.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic of Respiratory and Allergic Diseases Golnik | Golnik | 4204 | Slovenia |
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| 11 years |
| Identify features with the highest discriminatory power of lung cancer prediction and early detection. | 11 years |
| Identify features with the highest discriminatory power to distinguish between lung cancer patients in stage I-II and stage III-IV. | 11 years |
| Jozef Stefan Institute | Ljubljana | 1000 | Slovenia |
|
| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| D001984 | Bronchial Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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