Lung CancerONC006NCT02121899
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)
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 influencing treatment decisions of Oncologists when added to standard clinical-pathological parameters in patients with early stage NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, NSCLC, NSCLC Adenocarcinoma
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 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
- 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
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 Treatment Decisions and to Assess Disease-free Survival With Long-term Follow-up in Newly Diagnosed Early Stage Lung Adenocarcinoma Patients (LUNG CARE Registry)
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).
- Conditions
- Lung Cancer, NSCLC, NSCLC Adenocarcinoma
- Keywords
- Registry
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Assessment of disease free survival from resection to relapse or death
To estimate disease-free survival with the collection of long-term follow-up information (up to 3 years post-testing).
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 startApr 2015
- 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
- 44 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
- NCT02121899
- Sponsor's protocol ID
- myPlan ONC006
- Acronym
- ONC006
- 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 Treatment Decisions and to Assess Disease-free Survival With Long-term Follow-up in Newly Diagnosed Early Stage Lung Adenocarcinoma Patients (LUNG CARE Registry)
- ClinicalTrials.gov ID
- NCT02121899
- Acronym / sponsor ID
- ONC006 / myPlan ONC006
- Conditions
- Lung Cancer, NSCLC, NSCLC Adenocarcinoma
- Keywords
- Registry
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: company decision to terminate
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Myriad Genetic Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- 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 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).
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 (5 listed)
- 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
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 treatment recommendation to Post-test treatment initiated
Time frame: 3 months
The percentage change from the recorded Pre-Test treatment recommendation by the oncologist versus the Post-Test treatment initiated.
1 secondary outcome
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 5 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 treatment recommendation to Post-test treatment initiated (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.