NCT06074133

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
36mo left

Started Mar 2024

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Mar 2024Mar 2029

First Submitted

Initial submission to the registry

September 19, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

March 7, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

September 19, 2023

Last Update Submit

April 30, 2026

Conditions

Pulmonary Nodule

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

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 collectionProcedure: Chest Computed Tomography

Interventions

Blood collectionPROCEDURE

Undergo blood draw

Indeterminate Pulmonary Nodules
Chest Computed TomographyPROCEDURE

Undergo standard of care chest Computed Tomography

Indeterminate Pulmonary Nodules

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37203, United States

Location

VA Tennessee Valley Healthcare Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Eric Grogan, MD

    Vanderbilt University/Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Thoracic Surgery & Medicine

Study Record Dates

First Submitted

September 19, 2023

First Posted

October 10, 2023

Study Start

March 7, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2029

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(4)