A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules

Recruiting

• Conditions: Pulmonary Nodule

• Registration Number: NCT06074133
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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).

Study Timeline

• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-10
• Study Start: 2024-03-07
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-30
• Primary Completion: 2027-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (4)

Rocky Mountain Regional VA Medical Center; 🇺🇸 Aurora, Colorado, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Vanderbilt University/Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

VA Tennessee Valley Healthcare Center; 🇺🇸 Nashville, Tennessee, United States