Determination and Validation of a Multi-analyte Assay for Lung Cancer Screening

Study Overview
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Brief Summary
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This study is part of the development and validation of a non-invasive lung screening test which aim to identify early stage lung cancer in patients at high risk for lung cancer.

Detailed Description
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This is a prospective, case-control, multi-center, observational nonsignificant risk study. The study aims to collect blood and clinical data from subjects undergoing Low Dose CT (LDCT) for lung cancer screening and subjects with confirmed lung cancer.

Official Title
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Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: Blood collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - Cases: Current or past smokers, with at least 20 pack-years Subjects with either A high suspicion for lung cancer, with planned surgery to establish a definitive diagnosis within 60 days after date of blood collection OR treatment naive lung cancer patients Exclusion Criteria - Cases: Known diagnosis or treatment of any previous cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix Current lung cancer is known to be stage III or IV by pathology. Inclusion Criteria - Screening: - Current or past smokers, with at least 20 pack-years, undergoing LDCT for lung cancer screening Exclusion Criteria - Screening: Known diagnosis or treatment of any cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix Subjects whose purpose of performing LDCT is for surveillance of a lung nodule

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases Series<br>Subjects with confirmed lung cancer diagnosis | Procedure: Blood collection<br>* Peripheral blood will be collected via routine venipuncture procedure<br>|
| Screening Series<br>Subjects undergoing LDCT for lung cancer screening | Procedure: Blood collection<br>* Peripheral blood will be collected via routine venipuncture procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of blood samples | Collect blood to support the development and validation of a multi analyte test for lung cancer screening | 24 Months | 
| Clinical data collection | Collect clinical data to support the development and validation of a multi analyte test for lung cancer screening | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance | Performance of the assay in terms of (1) Sensitivity (2) Specificity (3) NPV (negative predictive value) and (4) PPV (positive predictive value) | 36 Months | 
| Sensitivity | Performance of the assay in terms of Sensitivity | 36 Months | 
| Specificity | Performance of the assay in terms of Specificity | 36 Months | 
| Negative Predictive Value | Performance of the assay in terms of NPV (negative predictive value) | 36 Months | 
| Positive Predictive Value | Performance of the assay in terms of PPV (positive predictive value) | 36 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LDCT, Low Dose CT, Lung Cancer Screening, liquid biopsy, early detection, lung cancer