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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Nodule
• Intervention / Treatment: Procedure: Blood collection; Procedure: Chest Computed Tomography

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Vanderbilt-Ingram Services for Timely Access; Phone Number: 800-811-8480; Email: cip@vumc.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Not yet recruiting
      • University of Colorado
      • Contact: Vanderbilt-Ingram Services for Timely Access; Phone Number: 800-811-8480; Email: cip@vumc.org
      • Principal Investigator: Anna 'Baron, PhD
    • Aurora, Colorado, United States, 80045
      • Not yet recruiting
      • Rocky Mountain Regional VA Medical Center
      • Contact: Vanderbilt-Ingram Services for Timely Access; Phone Number: 800-811-8480; Email: cip@vumc.org
      • Principal Investigator: Melissa New, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Vanderbilt University/Ingram Cancer Center
      • Principal Investigator: Eric Grogan, MD
      • Contact: Vanderbilt-Ingram Service Services for Timely Access; Phone Number: 800-811-8480; Email: cip@vumc.org
    • Nashville, Tennessee, United States, 37212
      • Not yet recruiting
      • VA Tennessee Valley Healthcare Center
      • Principal Investigator: Eric Grogan, MD
      • Contact: Vanderbilt-Ingram Services for Timely Access; Phone Number: 800-811-8480; Email: cip@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients recruited from pulmonary or thoracic clinics that have indeterminate pulmonary nodules

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Blood collection; Undergo blood draw; Procedure: Chest Computed Tomography; Undergo standard of care chest Computed Tomography

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Eric Grogan, MD, Vanderbilt University/Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: VICC-EDTHO23230; NCI-2023-05725 (Registry Identifier: NCI, Clinical Trials Reporting Program); 5R01CA252964-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No