A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules

Pulmonary Nodule Clinical Trial

Official title:

A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules A Multicenter Prospective Observational Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074133
• Other study ID #: VICC-EDTHO23230
• Secondary ID: NCI-2023-057255R
• Status: Recruiting
• Start date: March 7, 2024
• Est. completion date: March 31, 2029

Study information

• Verified date: March 2024
• Source: Vanderbilt-Ingram Cancer Center
• Contact: Vanderbilt-Ingram Services for Timely Access
• Phone: 800-811-8480
• Email: cip[@]vumc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2029
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodule

Intervention

Procedure:
• Blood collection
Undergo blood draw
• Chest Computed Tomography
Undergo standard of care chest Computed Tomography

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VA Medical Center	Aurora	Colorado
United States	University of Colorado	Aurora	Colorado
United States	VA Tennessee Valley Healthcare Center	Nashville	Tennessee
United States	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with benign disease who underwent invasive diagnostic procedures.		Up to approximately 2 years
Primary	The time to diagnosis (in days) for patients with cancer.		Up to approximately 2 years
Primary	Measure time needed to provide the CBM Value to clinician	Number of days	Up to approximately 2 years
Primary	Measure time needed to obtain hs CYFRA 21-1 values	Number of hours (days)	Up to approximately 2 years
Primary	Measure time needed to perform radiomics	Number of hours (days)	Up to approximately 2 years