Study Stopped
company decision to terminate
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)
1 other identifier
observational
44
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2014
CompletedFirst Posted
Study publicly available on registry
April 24, 2014
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2017
CompletedSeptember 5, 2017
September 1, 2015
2.2 years
April 22, 2014
August 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage change from Pre-Test treatment recommendation to Post-test treatment initiated
The percentage change from the recorded Pre-Test treatment recommendation by the oncologist versus the Post-Test treatment initiated.
3 months
Secondary Outcomes (1)
Assessment of disease free survival from resection to relapse or death
3 years
Eligibility Criteria
Recently diagnosed treatment-naïve patients with early stage NSCLC (lung adenocarcinoma)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Orlando, Florida, United States
Biospecimen
Formalin-fixed paraffin-embedded (FFPE) tissue from blocks or slides of prostatic adenocarcinoma biopsies.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Richard Wenstrup, MD
Myriad Genetic Laboratories, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2014
First Posted
April 24, 2014
Study Start
April 1, 2015
Primary Completion
June 30, 2017
Study Completion
July 31, 2017
Last Updated
September 5, 2017
Record last verified: 2015-09