Clinical trial NCT06074133: A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules
Official title: A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules A Multicenter Prospective Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Nodule
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-10-10
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recruited from pulmonary or thoracic clinics that have indeterminate pulmonary nodules

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).

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of patients with benign disease who underwent invasive diagnostic procedures.
timeFrame: Up to approximately 2 years
measure: The time to diagnosis (in days) for patients with cancer.
timeFrame: Up to approximately 2 years
measure: Measure time needed to provide the CBM Value to clinician
timeFrame: Up to approximately 2 years
measure: Measure time needed to obtain hs CYFRA 21-1 values
timeFrame: Up to approximately 2 years
measure: Measure time needed to perform radiomics
timeFrame: Up to approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center
state: Colorado
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Nashville
country: United States
facility: Vanderbilt University/Ingram Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: VA Tennessee Valley Healthcare Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University/Ingram Cancer Center
name: Eric Grogan, MD
role: PRINCIPAL_INVESTIGATOR
References: