Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay (LU-NGS-2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03558165|
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : July 5, 2019
|Condition or disease||Intervention/treatment|
|Lung Cancer Stage IV||Diagnostic Test: Oncomine Comprehensive Assay|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Cancer Panel|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2023|
|Stage IV Lung Adenocarcinoma||
Diagnostic Test: Oncomine Comprehensive Assay
Stage IV lung adenocarcinoma patients will have previously biopsied tumor tissue tested with the Oncomine Comprehensive Assay
- 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.
- 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).
- 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).
- 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.
- 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 learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558165
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Natasha Leighl, MD 416-946-4645 Natasha.Leighl@uhn.ca|
|Principal Investigator: Natasha Leighl, MD|