A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules A Multicenter Prospective Observational Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Blood collection
- Conditions
- Pulmonary Nodule
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Enrollment
- 100
- Locations
- 7
- Primary Endpoint
- The proportion of patients with benign disease who underwent invasive diagnostic procedures.
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
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
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).
Investigators
Eric Grogan
Professor of Thoracic Surgery & Medicine
Vanderbilt-Ingram Cancer Center
Eligibility Criteria
Inclusion Criteria
- •Adults \> 21 y/o
- •IPNs 8-30mm referred for evaluation Figure
- •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
Arms & Interventions
Indeterminate Pulmonary Nodules
A combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score will be obtained to estimate potential clinical utility compared to the Mayo Model.
Intervention: Blood collection
Indeterminate Pulmonary Nodules
A combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score will be obtained to estimate potential clinical utility compared to the Mayo Model.
Intervention: Chest Computed Tomography
Outcomes
Primary Outcomes
The proportion of patients with benign disease who underwent invasive diagnostic procedures.
Time Frame: Up to approximately 2 years
Measure time needed to provide the CBM Value to clinician
Time Frame: Up to approximately 2 years
Number of days
Measure time needed to obtain hs CYFRA 21-1 values
Time Frame: Up to approximately 2 years
Number of hours (days)
Measure time needed to perform radiomics
Time Frame: Up to approximately 2 years
Number of hours (days)
The time to diagnosis (in days) for patients with cancer.
Time Frame: Up to approximately 2 years