NCT06074133

A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pulmonary Nodule

Interventions

Type	Name	Description
PROCEDURE	Blood collection	Undergo blood draw
PROCEDURE	Chest Computed Tomography	Undergo standard of care chest Computed Tomography

Timeline

• Start date: 2024-03-07
• Primary completion: 2027-03-31
• Completion: 2029-03-31
• First posted: 2023-10-10
• Last updated: 2026-03-13

Locations

4 sites across 1 country: United States