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Keep this study
Lead
Exactis Innovation
This prospective multi-center 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 100 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 50 patients will have a tissue sample collected from pathology archives or planned biopsy or surgery.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with NSCLC, which is (i) advanced or metastatic (stage IIIb/IV), (ii) non- squamous histology NSCLC as confirmed by local histopathology (mixed squamous and adenocarcinoma is allowed), and has (iii) radiographically measurable disease with at least one bidimensionally measurable lesion of \> 1 cm by CT scan
No prior treatment for advanced or metastatic NSCLC, except for palliative radiation therapy to non-lung or non-thorax metastases. Patients who received palliative radiation therapy to metastases located within or approximately to the lung or thorax must be evaluated for eligibility.
Willing and able to provide adequate blood sample prior to starting treatment.
Willing to provide primary or metastatic tissue, if available.
Signed and dated Research Ethics Board (REB)-approved informed consent form for Exactis-01 or PMT.
Not pregnant or breastfeeding
You may not be if
Patients who have a history of another active cancer within the past 2 years from date of consent except cervical cancer in situ, basal cell carcinoma of the skin or another in situ carcinoma that is considered cured by the investigator.
Clareo Health | An Observational Study to Evaluate the Clinical Utility of the Oncomine Precision Assay Within the Exactis Network