Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay (LU-NGS-2)
May 16, 2022 updated by: University Health Network, Toronto
Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Cancer Panel
Currently, publicly funded standard of care testing in Ontario for stage IV lung cancer patients uses individual gene tests to look for mutations in the EGFR and ALK genes.
This testing broadens treatment options for patients, however there are other gene mutations with corresponding targeted treatments that are not routinely tested for.
This study will evaluate the utility and added value of using a next generation sequencing (NGS) panel, the Oncomine Comprehensive Assay v3, to profile stage IV lung cancer patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
134
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- Princess Margaret Cancer Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Eligible patients will be recruited at outpatient thoracic oncology clinics at the Princess Margaret Cancer Centre.
Description
Inclusion Criteria:
- Age ≥ 18 years of age
- Pathologic or cytologic confirmation of lung adenocarcinoma (mixed adenocarcinoma and sarcomatoid features permitted)
- Stage IV disease
- Sufficient FFPE tumour tissue for OCCP testing
- Performance status 0-2
- Candidates for targeted therapy (TKIs) and/or clinical trials as determined by the patient's medical oncologist
- Prognosis > 6 months
- Known translocations of RET, MET exon14 skipping variants, or MET amplification are allowed
Exclusion Criteria:
● Patients with known EGFR, KRAS, BRAF and ERBB2 mutations or ALK or ROS1 fusions at study entry unless acquired resistance to molecularly targeted therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Stage IV Lung Adenocarcinoma
|
Stage IV lung adenocarcinoma patients will have previously biopsied tumor tissue tested with the Oncomine Comprehensive Assay
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incremental actionable targets
Time Frame: 8-12 weeks from Oncomine Comprehensive Assay testing
|
Calculate the number of incremental actionable targets identified by the Oncomine Comprehensive Assay compared to current standard of care molecular profiling (EGFR, ALK) in patients with stage IV NSCLC.
|
8-12 weeks from Oncomine Comprehensive Assay testing
|
|
Number of clinical trial opportunities
Time Frame: 1 year from Oncomine Comprehensive Assay testing
|
Compile the number of clinical trial opportunities that patients with stage IV NSCLC would be eligible for based on targets identified by the Oncomine Comprehensive Assay compared to standard of care molecular profiling (EGFR, ALK).
|
1 year from Oncomine Comprehensive Assay testing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Test turnaround time
Time Frame: To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).
|
Calculate the time to receive Oncomine Comprehensive Assay results compared to the standard of care tissue molecular test turnaround time (EGFR, ALK).
|
To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).
|
|
Financial feasibility
Time Frame: To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).
|
Perform a cost consequence analysis to evaluate financial feasibility of the Oncomine Comprehensive Assay.
|
To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).
|
|
Patient willingness-to-pay
Time Frame: To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).
|
Evaluate patient willingness-to-pay for using a next generation sequencing assay, like the Oncomine Comprehensive Assay, using a validated patient survey.
|
To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2018
Primary Completion (Actual)
August 20, 2020
Study Completion (Actual)
February 18, 2022
Study Registration Dates
First Submitted
May 7, 2018
First Submitted That Met QC Criteria
June 4, 2018
First Posted (Actual)
June 15, 2018
Study Record Updates
Last Update Posted (Actual)
May 17, 2022
Last Update Submitted That Met QC Criteria
May 16, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-5638
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.