A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules

Recruiting

• Conditions: Pulmonary Nodule
• Interventions: Procedure: Blood collection; Procedure: Chest Computed Tomography

• 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

Arm && Interventions

Group	Intervention	Description
Indeterminate Pulmonary Nodules	Blood collection	A combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score will be obtained to estimate potential clinical utility compared to the Mayo Model.
Indeterminate Pulmonary Nodules	Chest Computed Tomography	A combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score will be obtained to estimate potential clinical utility compared to the Mayo Model.

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)

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

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

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

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