Lung CancerONC003NCT02121925
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
An observational study of Lung Cancer and NSCLC, run by Myriad Genetic Laboratories, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, NSCLC, Lung Adenocarcinoma
- How many people
- 227 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 31 Jul 2017
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recently diagnosed treatment-naïve patients with early stage NSCLC (lung adenocarcinoma)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Lung Cancer, NSCLC, Lung Adenocarcinoma
- Keywords
- Registry
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma of Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (4)
Percentage change from the Pre-test referral to the 60-day Post-Test referral
The percentage change from the recorded Pre-Test referral by surgeon versus the 60 day post-test actual referral attendance
Measured: 2 months
Percentage of patients at 60 days post test receiving treatment
The percentage of patients at 60 day post-test who are receiving radiation and or chemotherapy treatment
Measured: 2 months
Percentage change from Pre-Test to Post-Test chest surveillance plan
The percentage change from the recorded Pre-Test chest surveillance plan versus the Post-Test chest surveillance plan
Measured: 3 months
Assessment of disease free survival from resection to relapse or death
Disease-free survival, which is defined as the time from resection to the first of two events: lung cancer relapse or death from any cause
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startMay 2014
- Primary completion30 Jun 2017
- Study completion31 Jul 2017
Why it stopped: Company decision to terminate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 227 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Myriad Genetic Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Wenstrup, MD, Study director, Myriad Genetic Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121925
- Sponsor's protocol ID
- myPlan ONC003
- Acronym
- ONC003
- Status last verified
- Sep 2015
- First submitted
- 22 Apr 2014
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02121925
- Acronym / sponsor ID
- ONC003 / myPlan ONC003
- Conditions
- Lung Cancer, NSCLC, Lung Adenocarcinoma
- Keywords
- Registry
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Company decision to terminate
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Myriad Genetic Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recently diagnosed treatment-naïve patients with early stage NSCLC (lung adenocarcinoma)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage change from Pre-Test to Post-Test referral
Time frame: 3 months
The percentage change from the recorded PRE-TEST referral by surgeon versus the POST-TEST referral following results of myPlan Lung Cancer testing
4 secondary outcomes
Percentage change from the Pre-test referral to the 60-day Post-Test referral
Time frame: 2 months
Percentage of patients at 60 days post test receiving treatment
Time frame: 2 months
Percentage change from Pre-Test to Post-Test chest surveillance plan
Time frame: 3 months
Assessment of disease free survival from resection to relapse or death
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Company decision to terminate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Wenstrup, MD study director
Myriad Genetic Laboratories, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and NSCLC, run by Myriad Genetic Laboratories, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Company decision to terminate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from Pre-Test to Post-Test referral (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.