An Observational Study to Evaluate the Clinical Utility of the Oncomine Precision Assay Within the Exactis Network

Official Title

A Multi-Centre Observational Study to Evaluate the Clinical Utility of Returning Genomic Aberration Results Using the Oncomine Precision Assay in Advanced or Metastatic Non-Small Cell Lung Cancer Within the Exactis Network

Summary:

A Multi-centre Observational Study to Evaluate the Clinical Utility of Returning Genomic Aberration results Using the Oncomine Precision Assay in Advanced or Metastatic Non-Small Cell Lung Cancer Patients within the Exactis Network

Trial Description

Primary Outcome:

• Demonstrate the non-inferiority of the Oncomine Precision Assay vs Standard of Care

Secondary Outcome:

• Clinical utility of returning genomic aberration results by quantifying the number of patients who received targeted therapy based on results returned from the Oncomine Precision Assay genomic aberration results in blood and/or tissue
• Clinical utility of returning genomic aberration results by quantifying the number of patients enrolled on a clinical trial based on results returned from the Oncomine Precision Assay in blood and/or tissue
• Clinical utility of returning genomic aberration results by measuring the turnaround time (in days) from the date of request for SOC genetic testing in tissue versus date of blood collection for the Oncomine Precision Assay to the report date

This prospective multi-centre observational study will evaluate the clinical utility of returning genomic aberration results in blood and/or tissue using the Oncomine Precision Assay in non-small cell lung cancer (NSCLC) patients. Up to 200 patients with stage IIIb/IV NSCLC will consent to have their blood and tissue profiled on the Oncomine Precision Assay. A baseline plasma sample will be collected for all patients, of which up to 100 patients will have a tissue sample collected from pathology archives or planned biopsy or surgery.

View this trial on ClinicalTrials.gov