RecruitingNCT06074133

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

Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

100 participants

Start Date

Mar 7, 2024

Study Type

OBSERVATIONAL

Conditions

Pulmonary Nodule

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

Min Age: 21 Years

Inclusion Criteria5

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 Criteria9

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

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