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 Cancer Clinical Trial

— ONC003  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02121925
• Other study ID #: myPlan ONC003
• Status: Terminated
• Phase: N/A
• First received: April 22, 2014
• Last updated: August 31, 2017
• Start date: May 2014
• Est. completion date: July 31, 2017

Study information

• Verified date: September 2015
• Source: Myriad Genetic Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 227
• Est. completion date: July 31, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Lung Adenocarcinoma
• Lung Cancer
• Lung Neoplasms
• NSCLC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Myriad Genetic Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Secondary	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	2 months
Secondary	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	2 months
Secondary	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	3 months
Secondary	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	3 years