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)

August 31, 2017 updated by: Myriad Genetic Laboratories, Inc.

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

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 Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

227

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Recently diagnosed treatment-naïve patients with early stage NSCLC (lung adenocarcinoma)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage change from Pre-Test to Post-Test referral
Time Frame: 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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage change from the Pre-test referral to the 60-day Post-Test referral
Time Frame: 2 months
The percentage change from the recorded Pre-Test referral by surgeon versus the 60 day post-test actual referral attendance
2 months
Percentage of patients at 60 days post test receiving treatment
Time Frame: 2 months
The percentage of patients at 60 day post-test who are receiving radiation and or chemotherapy treatment
2 months
Percentage change from Pre-Test to Post-Test chest surveillance plan
Time Frame: 3 months
The percentage change from the recorded Pre-Test chest surveillance plan versus the Post-Test chest surveillance plan
3 months
Assessment of disease free survival from resection to relapse or death
Time Frame: 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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myriad Genetic Laboratories, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

July 31, 2017

Study Registration Dates

First Submitted

April 22, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 24, 2014

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • myPlan ONC003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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