NCT02121899

Terminated

Registry Measuring Impact of RNA Expression Testing on Treat...

Myriad Genetic Laboratories, Inc.Source

NCT02121899|Terminated

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)

Myriad Genetic Laboratories, Inc.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

myPlan ONC006

Study Type

observational

Actual enrollment (reported)

44

Locations

1 country

Sites

1

Timeline

Study Start

April 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 30, 2017

Actual (reported)

Study Completion

July 31, 2017

Actual (reported)

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).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 44 participants
Study completion date: July 31, 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 22, 2014
Actual (reported)
First Posted
April 24, 2014
Actual (reported)
Study Start
April 2015
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
June 30, 2017
Actual (reported)
Study Completion
July 31, 2017
Actual (reported)

Last Updated: September 5, 2017
Status Verified: September 2015
Last Update Submitted: August 31, 2017

Conditions

Lung Cancer NSCLC NSCLC Adenocarcinoma

Keywords

Registry

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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

Diagnosis of early stage non-small cell lung adenocarcinoma

Sponsors & Collaborators

Myriad Genetic Laboratories, Inc.
Industrylead

Study Sites (1)

Orlando, Florida, United States

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed paraffin-embedded (FFPE) tissue from blocks or slides of prostatic adenocarcinoma biopsies.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

Richard Wenstrup, MD
Myriad Genetic Laboratories, Inc.
STUDY DIRECTOR

Enrollment

44 participants (actual enrollment reported by the registry).

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 2015

Date type not reported

This date has not been verified as actual or estimated.

Recruiting

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Phase 2Terminated

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Not ApplicableCompleted

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Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer

Not ApplicableCompleted

NCT02321540

A Phase I/II Study of Ibrutinib in Previously Treated Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer

Phase 1/2Completed

NCT02063828

Reducing Lung Cancer-Related Anxiety (RELAX)

Not ApplicableTerminated

NCT02285855

Metformin in Non Small Cell Lung Cancer (NSCLC)

Phase 2Terminated

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.

Primary Completion

June 30, 2017

Actual (reported)

Study Completion

July 31, 2017

Actual (reported)

Last Updated

September 5, 2017

Record last verified: 2015-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02121899
Data provider: ClinicalTrials.gov
Source updated: 2017-09-05
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:21 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations