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

Terminated

• Conditions: Lung Cancer; Lung Adenocarcinoma; NSCLC

• Registration Number: NCT02121925
• Lead Sponsor: Myriad Genetic Laboratories, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-24
• Study Start: 2014-05
• Status Verified: 2015-09
• Primary Completion: 2017-06-30
• Study Completion: 2017-07-31
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 227

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assessment of disease free survival from resection to relapse or death	3 years	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
Percentage change from the Pre-test referral to the 60-day Post-Test referral	2 months	The percentage change from the recorded Pre-Test referral by surgeon versus the 60 day post-test actual referral attendance
Percentage change from Pre-Test to Post-Test chest surveillance plan	3 months	The percentage change from the recorded Pre-Test chest surveillance plan versus the Post-Test chest surveillance plan
Percentage of patients at 60 days post test receiving treatment	2 months	The percentage of patients at 60 day post-test who are receiving radiation and or chemotherapy treatment