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)

Myriad Genetic Laboratories, Inc.44 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lung Cancer NSCLC NSCLC Adenocarcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

Percentage change from Pre-Test treatment recommendation to Post-test treatment initiated

The percentage change from the recorded Pre-Test treatment recommendation by the oncologist versus the Post-Test treatment initiated.

Time frame: 3 months

Secondary Outcomes

Assessment of disease free survival from resection to relapse or death

To estimate disease-free survival with the collection of long-term follow-up information (up to 3 years post-testing).

Time frame: 3 years