Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Assess Test Performance of AAT test | To assess the performance of the AAT test in a real-world patient population:
| Up to 24 months |
| Assess Test Performance of IC test | To assess the performance of the IC test in a real-world population:
| 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 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess ATT Test Accuracy | To assess the accuracy of the AAT post-test risk of malignancy by comparing with the actual patient outcome.
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess Test Performance in Sub-Populations | Assess the performance of the AAT and IC tests in patient subpopulations.
|
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients that have previously been tested with the AAT and IC tests and have at least 1 year of follow up data.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Jett, MD | Biodesix, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary & Sleep of Tampa Bay | Brandon | Florida | 33511 | United States | ||
| White-Wilson Medical Center |
Not provided
| Label | URL |
|---|---|
| Sponsor website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 24 months |
| Determine Health Outcomes | To determine one-year health outcomes of patients stratified by AAT and IC tests result risk categories.
| Up to 24 months |
| Up to 24 months |
| Assess Test Performance in Populations Outside of Validation | To assess the performance of the AAT and IC tests in populations outside of their primary validated populations.
| Up to 24 months |
| Fort Walton Beach |
| Florida |
| 32548 |
| United States |
| The Lung and Sleep Disorder Institute | Somerset | Kentucky | 42503 | United States |
| Southcoast Health System | Fairhaven | Massachusetts | 02720 | United States |
| The Lung Center, PC | DuBois | Pennsylvania | 15801 | United States |