A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules A Multicenter Prospective Observational Pilot Study

Conditions
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Pulmonary Nodule

Intervention / Treatment
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* Procedure: Blood collection
* Procedure: Chest Computed Tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Indeterminate Pulmonary Nodules<br>A combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score will be obtained to estimate potential clinical utility compared to the Mayo Model. | Procedure: Blood collection<br>* Undergo blood draw<br>Procedure: Chest Computed Tomography<br>* Undergo standard of care chest Computed Tomography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with benign disease who underwent invasive diagnostic procedures. |  | Up to approximately 2 years | 
| The time to diagnosis (in days) for patients with cancer. |  | Up to approximately 2 years | 
| Measure time needed to provide the CBM Value to clinician | Number of days | Up to approximately 2 years | 
| Measure time needed to obtain hs CYFRA 21-1 values | Number of hours (days) | Up to approximately 2 years | 
| Measure time needed to perform radiomics | Number of hours (days) | Up to approximately 2 years |