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

N/ATerminatedNCT02121925

Myriad Genetic Laboratories, Inc.227 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

227

Conditions

Lung Cancer NSCLC Lung 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: * 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 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

Time frame: 3 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 3 years