Overview
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.
Description
- Objectives
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- 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).
Eligibility
Inclusion Criteria:
- Adults > 21 y/o
- IPNs 8-30mm referred for evaluation Figure 4. AUC and reclassification of Combined Biomarker Model
- Intermediate risk IPN defined as 10-70% risk after applying Mayo risk predictor model
- Solid nodules or part-solid nodules with solid component >=8mm
- CT scan with nodule of concern performed within 60 days of enrollment
Exclusion Criteria:
Pure ground glass nodule or subsolid nodule with solid component <8mm
- Currently on therapy for any cancer
- History of primary lung cancer within the last 5 years
- Multiple nodules highly suspicious for metastatic disease
- Other malignancy within the last 2 year - Excluding skin cancer other than melanoma
- Pregnant women
- Prisoners
- Inability to provide informed consent
- Serologic evidence of active fungal infection