Status:
RECRUITING
A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pulmonary Nodule
Eligibility:
All Genders
21+ years
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. * ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06074133
Start Date
March 7 2024
End Date
March 31 2029
Last Update
August 20 2025
Active Locations (4)
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1
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States, 80045
2
University of Colorado
Aurora, Colorado, United States, 80045
3
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37203
4
VA Tennessee Valley Healthcare Center
Nashville, Tennessee, United States, 37212