NCT02121925

Terminated

Registry Measuring the Impact of Adding RNA Expression Testi...

Myriad Genetic Laboratories, Inc.Source

NCT02121925|Terminated

Study Stopped

Company decision to terminate

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

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

Myriad Genetic Laboratories, Inc.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

myPlan ONC003

Study Type

observational

Actual enrollment (reported)

227

Locations

1 country

Sites

1

Timeline

Study Start

May 2014

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 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.

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): 227 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
May 2014
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 Adenocarcinoma Lung Cancer NSCLC

Keywords

Registry

Outcome Measures

Primary Outcomes (1)

Percentage change from Pre-Test to Post-Test referral
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 Outcomes (4)

Percentage change from the Pre-test referral to the 60-day Post-Test referral
2 months
Percentage of patients at 60 days post test receiving treatment
2 months
Percentage change from Pre-Test to Post-Test chest surveillance plan
3 months
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)

Seattle, Washington, 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 NeoplasmsAdenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

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

Enrollment

227 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

May 2014

Date type not reported

This date has not been verified as actual or estimated.

Phase 1/2Withdrawn

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Recruiting

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Phase 1Completed

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Phase 1/2Terminated

NCT01219348

IDO Peptid Vaccination for Stage III-IV Non Small-cell Lung Cancer Patients.

Phase 1Completed

NCT02183870

EUCROSS: European Trial on Crizotinib in ROS1 Translocated Lung Cancer

Phase 2Completed

NCT01883986

Supportive Care for Patients Newly Diagnosed With Lung Cancer

Not ApplicableCompleted

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:

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: NCT02121925
Data provider: ClinicalTrials.gov
Source updated: 2017-09-05
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:10 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 (4)

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