A Multicenter, Retrospective, Chart Review Study Evaluating the Impact and Utility of the Blood-Based Proteomic Integrated Classifier and Auto-Antibody Tests in the Real-World

Biodesix, Inc.5 sites in 1 country4,000 target enrollmentSeptember 19, 2024

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

September 19, 2024

End Date

July 31, 2027

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Biodesix, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients treated at sites with ≥100 patients who have been evaluated with the IC and AAT tests.
•Patients who are at least 40 years of age on the index date.
•Patients who have index dates (date of IC and AAT testing) at least one year prior to data collection date.

Exclusion Criteria

•Patients with no prior AAT and/or IC testing at the study site.
•Patients less than 40 years of age on the index date.

Outcomes

Primary Outcomes

Assess Test Performance of AAT test

Time Frame: Up to 24 months

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

Assess Test Performance of IC test

Time Frame: 24 months

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

Assess serial performance of serial testing with the AAC and IC tests.

Time Frame: 24 months

Assess the performance of the of serial testing with the AAC and IC tests