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

NCT ID: NCT02121925

Last Updated: 2017-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

227 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer NSCLC Lung Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Myriad Genetic Laboratories, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Wenstrup, MD

Role: STUDY_DIRECTOR

Myriad Genetic Laboratories, Inc.

Locations

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Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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myPlan ONC003

Identifier Type: -

Identifier Source: org_study_id

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