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| Name | Class |
|---|---|
| Princess Margaret Hospital, Canada | OTHER |
| The Princess Margaret Cancer Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage IV Lung Adenocarcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oncomine Comprehensive Assay | Diagnostic Test | Stage IV lung adenocarcinoma patients will have previously biopsied tumor tissue tested with the Oncomine Comprehensive Assay |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incremental actionable targets | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Test turnaround time | 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 |
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Inclusion Criteria:
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
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Eligible patients will be recruited at outpatient thoracic oncology clinics at the Princess Margaret Cancer Centre.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35278845 | Derived | Perdrizet K, Stockley TL, Law JH, Smith A, Zhang T, Fernandes R, Shabir M, Sabatini P, Youssef NA, Ishu C, Li JJ, Tsao MS, Pal P, Cabanero M, Schwock J, Ko HM, Boerner S, Ruff H, Shepherd FA, Bradbury PA, Liu G, Sacher AG, Leighl NB. Integrating comprehensive genomic sequencing of non-small cell lung cancer into a public healthcare system. Cancer Treat Res Commun. 2022;31:100534. doi: 10.1016/j.ctarc.2022.100534. Epub 2022 Feb 18. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 | 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). |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |