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)

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02121899

Acronym

ONC006

Enrollment

Registered

2014-04-24

Start date

2015-04-30

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 Cancer, NSCLC, NSCLC Adenocarcinoma

Keywords

Registry

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).

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

United States

Outcome results