The primary Study hypothesis is that the ProLung Test will demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer. A statistically significant result will indicate that patients with a high ProLung Test result have a greater risk of developing lung cancer than patients with a low test result. There are three Specific Aims of this study: 1. Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in patients with a diagnosis. 2. Externally validate the efficacy of the ProLung Test risk-stratification algorithm by comparing the test result to the conclusive patient diagnosis. 3. Assess the safety and tolerability of the ProLung Test procedures. Study Design This Study consists of two distinct phases, Stabilization and Validation. The Study will collect data from multiple sites (3 to 12), and each site may enroll patients and collect data for the Stabilization and Validation Phases with a minimum of three sites for the Validation Phase.
Study Type
OBSERVATIONAL
Enrollment
420
UCLA Medical Center
Los Angeles, California, United States
UCSD Medical Center
San Diego, California, United States
Stanford University Medical Center
Stanford, California, United States
Loyola University Medical Center
Maywood, Illinois, United States
Greater Baltimore Medical Center
Towson, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Medical Center
Detroit, Michigan, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Wake Forest University
Winston-Salem, North Carolina, United States
...and 5 more locations
Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions
Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer.
Time frame: The ProLung Test will be performed within 60 days of a CT Scan that identifies a lung lesion suspicious for lung cancer and evaluated once a patient diagnosis is obtained.
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