Registry Measuring the Impact of Adding RNA Expression Testing on Referral Decisions in Early Stage Lung Cancer Patients and Assessing the Disease-free Survival With Long-term Follow-up

Study Overview
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Brief Summary
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This registry is intended to measure the effect of myPlan Lung Cancer™ test has on treatment decisions of Surgeons when added to standard clinical-pathological parameters in patients with early stage NSCLC.The sponsor is conducting two parallel registries, with one directed at Surgeons (ONC003) and the other at Oncologists (ONC006).This registry is specific to Surgeons (ONC003). Outcomes measures on lung cancer relapse and death from any cause will be collected.

Official Title
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LUNG CAncerREgistry: An Open Registry to Measure the Impact of Adding RNA Expression Testing (myPlan Lung Cancer) on Referral Decisions and to Assess Disease-free Survival With Long-term Follow-up in Newly Diagnosed Early Stage Lung Adenocarcinoma Patients

Conditions
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Lung Cancer, NSCLC, Lung Adenocarcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of early stage non-small cell lung adenocarcinoma Sub-population staging (IA, IB or IIA) as judged by the standard of practice at the investigational site Resection of tumor within previous 2 months of enrollment ECOG performance of 0-2 A minimum life expectancy of six months Exclusion Criteria: Pre-operative radiation or chemotherapy for NSCLC Post-operative radiation or chemotherapy for NSCLC Enrollment in a separate clinical trial restricting treatment options Unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from Pre-Test to Post-Test referral | The percentage change from the recorded PRE-TEST referral by surgeon versus the POST-TEST referral following results of myPlan Lung Cancer testing | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from the Pre-test referral to the 60-day Post-Test referral | The percentage change from the recorded Pre-Test referral by surgeon versus the 60 day post-test actual referral attendance | 2 months | 
| Percentage of patients at 60 days post test receiving treatment | The percentage of patients at 60 day post-test who are receiving radiation and or chemotherapy treatment | 2 months | 
| Percentage change from Pre-Test to Post-Test chest surveillance plan | The percentage change from the recorded Pre-Test chest surveillance plan versus the Post-Test chest surveillance plan | 3 months | 
| Assessment of disease free survival from resection to relapse or death | Disease-free survival, which is defined as the time from resection to the first of two events: lung cancer relapse or death from any cause | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Registry