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

LUNG CAncerREgistry: An Open Registry to Measure the Impact of Adding RNA Expression Testing (myPlan Lung Cancer) on Referral Decisions and to Assess Disease-free Survival With Long-term Follow-up in Newly Diagnosed Early Stage Lung Adenocarcinoma Patients

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02121925

Acronym

ONC003

Enrollment

227

Registered

2014-04-24

Start date

2014-05-31

Completion date

2017-07-31

Last updated

2017-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Adenocarcinoma, Lung Cancer, NSCLC

Keywords

Registry

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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
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
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

Countries

United States

Outcome results