A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules
Purpose
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.
Condition
- Pulmonary Nodule
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
Nashville, Tennessee 37203
Aurora, Colorado 80045
More Details
- Status
- Recruiting
- Sponsor
- Vanderbilt-Ingram Cancer Center
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).