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

Active, not recruiting

• Conditions: Lung Nodules

• Registration Number: NCT06728319
• Lead Sponsor: Biodesix, Inc.

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.

Study Timeline

• Study Start: 2024-09-19
• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-07
• Primary Completion: 2026-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess Test Performance of IC test	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.	24 months	Assess the performance of the of serial testing with the AAC and IC tests
Assess Test Performance of AAT test	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

Secondary Outcome Measures

Name	Time	Method
Determine Health Outcomes	Up to 24 months	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.
Assess ATT Test Accuracy	Up to 24 months	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.

Trial Locations

Locations (5)

Pulmonary & Sleep of Tampa Bay; 🇺🇸 Brandon, Florida, United States

White-Wilson Medical Center; 🇺🇸 Fort Walton Beach, Florida, United States

Southcoast Health System; 🇺🇸 Fairhaven, Massachusetts, United States

The Lung Center, PC; 🇺🇸 DuBois, Pennsylvania, United States

The Lung and Sleep Disorder Institute; 🇺🇸 Somerset, Kentucky, United States