A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules

Last updated: August 14, 2025
Sponsor: Vanderbilt-Ingram Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pulmonary Nodules

Treatment

Chest Computed Tomography

Blood collection

Clinical Study ID

NCT06074133
VICC-EDTHO23230
NCI-2023-05725
5R01CA252964-02
  • Ages > 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults > 21 y/o

  • IPNs 8-30mm referred for evaluation Figure 4. AUC and reclassification of CombinedBiomarker Model

  • Intermediate risk IPN defined as 10-70% risk after applying Mayo risk predictormodel

  • Solid nodules or part-solid nodules with solid component >=8mm

  • CT scan with nodule of concern performed within 60 days of enrollment

Exclusion

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

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Chest Computed Tomography
Phase:
Study Start date:
March 07, 2024
Estimated Completion Date:
March 31, 2029

Study 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).

Connect with a study center

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • VA Tennessee Valley Healthcare Center

    Nashville, Tennessee 37212
    United States

    Active - Recruiting

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

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