This is an observational study designed to determine the optimal combination of biomarkers and clinical data for the early detection, confirmation, and better treatment of lung cancer including minimizing recurrence.
Peripheral venous blood and clinical data will be collected from consented subjects with lung nodules identified in radiology that are suspicious for lung cancer before invasive diagnosis or treatment is initiated. Various analyses will be conducted to determine which subset of biomarkers is most likely to be the most useful in the clinic. Attributes considered are accuracy (sensitivity, specificity, improvement over other methods) and ease of collection and transport. Results will not be reported to treating physicians and will not alter care of the patient.
Study Type
OBSERVATIONAL
Enrollment
2,000
Maverix Medical
Phoenix, Arizona, United States
RECRUITINGTest performance
Analytical validity, clinical validity, and clinical utility. Ability to correctly re-risk indeterminate nodules and ability to change clinical care based on hypothetical treatment plans for different test outcomes. Actual test results will not be provided to physicians, and actual care will not be affected.
Time frame: Two years from final case enrollment
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