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 (ONC003)

Myriad Genetic Laboratories

Status: Terminated

Conditions: Lung Cancer; Lung Adenocarcinoma; NSCLC

Study type: Observational

Funder types: Industry

Identifiers

NCT02121925

myPlan ONC003

Details and patient eligibility

About

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.

Enrollment: 227 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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