- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02121899
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) (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)
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).
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Florida
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Orlando, Florida, United States
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
- 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
Study Plan
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 treatment recommendation to Post-test treatment initiated
Time Frame: 3 months
|
The percentage change from the recorded Pre-Test treatment recommendation by the oncologist versus the Post-Test treatment initiated.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of disease free survival from resection to relapse or death
Time Frame: 3 years
|
To estimate disease-free survival with the collection of long-term follow-up information (up to 3 years post-testing).
|
3 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- myPlan ONC006
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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