Registry Measuring Impact of RNA Expression Testing on Treatment Decisions in Early Stage Lung Cancer and Assessing the Disease-free Survival With Long-term Follow-up (ONC006)

Terminated

• Conditions: NSCLC; NSCLC Adenocarcinoma; Lung Cancer

• Registration Number: NCT02121899
• Lead Sponsor: Myriad Genetic Laboratories, Inc.

Brief Summary

This registry is intended to measure the effect of myPlan Lung Cancer™ test has on influencing treatment decisions of Oncologists 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 Oncologists (ONC006).

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: 2015-04
• 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: 44

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

• Previous myPlan Lung Cancer test performed
• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage change from Pre-Test treatment recommendation to Post-test treatment initiated	3 months	The percentage change from the recorded Pre-Test treatment recommendation by the oncologist versus the Post-Test treatment initiated.

Secondary Outcome Measures

Name	Time	Method
Assessment of disease free survival from resection to relapse or death	3 years	To estimate disease-free survival with the collection of long-term follow-up information (up to 3 years post-testing).