This study is a multicenter retrospective chart review. Sites with at least 100 patients tested with the IC and AAT tests, who have index dates (date of IC and AAT testing) at least one year prior to data collection date will be eligible for participation.
This study is a multicenter retrospective chart review. Sites with at least 100 patients tested with the IC and AAT tests, who have index dates (date of IC and AAT testing) at least one year prior to data collection date will be eligible for participation. The protocol will require institutional IRB approval and a waiver of patient consent will be obtained. The data to be collected will be de-identified when entered into the study database. The collection of this de-identified data does not pose any risk to the subjects and does not require any further testing of the patient. The chart review will utilize a third-party Clinical Research Associate (CRA) with certified ICH-GCP training for data collection and documentation. Biodesix, Inc. in conjunction with the CRA will develop and maintain the Electronic Data Capture (EDC) system.
Study Type
OBSERVATIONAL
Enrollment
4,000
Pulmonary & Sleep of Tampa Bay
Brandon, Florida, United States
White-Wilson Medical Center
Fort Walton Beach, Florida, United States
The Lung and Sleep Disorder Institute
Somerset, Kentucky, United States
Southcoast Health System
Fairhaven, Massachusetts, United States
Assess Test Performance of AAT test
To assess the performance of the AAT test in a real-world patient population: 1. Sensitivity of the AAT test at 24 months 2. Specificity of the AAT test at 24 months 3. Positivity predictive value of the AAT test at 24 months
Time frame: Up to 24 months
Assess Test Performance of IC test
To assess the performance of the IC test in a real-world population: 1. Sensitivity of the IC test at 24 months 2. Specificity of the IC test at 24 months 3. Negative predictive value of the IC test at 24 months
Time frame: 24 months
Assess serial performance of serial testing with the AAC and IC tests.
Assess the performance of the of serial testing with the AAC and IC tests
Time frame: 24 months
Assess ATT Test Accuracy
To assess the accuracy of the AAT post-test risk of malignancy by comparing with the actual patient outcome. * Compare the AAT test predicted proportion of malignant nodules to the actual proportion of malignant nodules by probability decile. * Compare the IC test predicted proportion of malignant nodules to the actual proportion of malignant nodules by probability decile.
Time frame: Up to 24 months
Determine Health Outcomes
To determine one-year health outcomes of patients stratified by AAT and IC tests result risk categories. * The number and type of invasive diagnostic procedure performed on newly identified nodules stratified by AAT test results. * The number of patients routed to CT surveillance following initial nodule evaluation that result in nodule resolution or up to 24-month radiographic stability stratified by the AAT test. * The number and type of invasive diagnostic procedures performed on newly identified nodules stratified by IC test results. * The number of patients routed to CT surveillance following initial nodule evaluation that result in nodule resolution or up to 24-month radiographic stability stratified by the IC test. * The number of malignant nodules identified following a diagnostic procedure stratified by histology and stage. * The number of specific benign nodules identified following a diagnostic procedure, stratified by pathological findings.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Lung Center, PC
DuBois, Pennsylvania, United States
Time frame: Up to 24 months