This is a prospective, multicenter observational study aim at estimating the potential clinical utility of the CBM and at establishing the SOPs and protocols for a future randomized control trial.
Objectives: * To obtain the combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score in a prospective observational trial and estimate potential clinical utility compared to the Mayo Model. * To establish standard operating procedures (SOPs) and protocols in a prospective observational trial in anticipation of a future randomized control trial. These include the REDCAP data input protocols, the radiomic protocols, blood draws in the CLIA environment, and estimating the CBM score in a time reasonable for clinical practice (\< 2 weeks).
Study Type
OBSERVATIONAL
Enrollment
103
Undergo blood draw
Undergo standard of care chest Computed Tomography
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
University of Colorado
Aurora, Colorado, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
VA Tennessee Valley Healthcare Center
Nashville, Tennessee, United States
The proportion of patients with benign disease who underwent invasive diagnostic procedures.
Time frame: Up to approximately 2 years
The time to diagnosis (in days) for patients with cancer.
Time frame: Up to approximately 2 years
Measure time needed to provide the CBM Value to clinician
Number of days
Time frame: Up to approximately 2 years
Measure time needed to obtain hs CYFRA 21-1 values
Number of hours (days)
Time frame: Up to approximately 2 years
Measure time needed to perform radiomics
Number of hours (days)
Time frame: Up to approximately 2 years
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