Pulmonary Nodule
Conditions
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. * 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).
Interventions
PROCEDUREBlood collection
Undergo blood draw
PROCEDUREChest Computed Tomography
Undergo standard of care chest Computed Tomography
Sponsors
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to approximately 2 years | Number of days |
| Measure time needed to obtain hs CYFRA 21-1 values | Up to approximately 2 years | Number of hours (days) |
| Measure time needed to perform radiomics | Up to approximately 2 years | Number of hours (days) |
Countries
United States
Contacts
CONTACTVanderbilt-Ingram Services for Timely Access
PRINCIPAL_INVESTIGATOREric Grogan, MD
Vanderbilt University/Ingram Cancer Center
Outcome results
None listed