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A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules

Pulmonary Nodule Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06074133
Study type Observational
Source Vanderbilt-Ingram Cancer Center
Contact Vanderbilt-Ingram Services for Timely Access
Phone 800-811-8480
Email cip@vumc.org
Status Recruiting
Phase
Start date March 7, 2024
Completion date March 31, 2029
View Details
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