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 (CLARIFY)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Nodules

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 Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

Study Locations

• United States
  • Florida
    • Brandon, Florida, United States, 33511
      • Pulmonary & Sleep of Tampa Bay
    • Fort Walton Beach, Florida, United States, 32548
      • White-Wilson Medical Center
  • Kentucky
    • Somerset, Kentucky, United States, 42503
      • The Lung and Sleep Disorder Institute
  • Massachusetts
    • Fairhaven, Massachusetts, United States, 02720
      • Southcoast Health System
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • The Lung Center, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients that have previously been tested with the AAT and IC tests and have at least 1 year of follow up data.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess Test Performance of AAT test	To assess the performance of the AAT test in a real-world patient population: Sensitivity of the AAT test at 24 months; Specificity of the AAT test at 24 months; Positivity predictive value of the AAT test at 24 months	Up to 24 months
Assess Test Performance of IC test	To assess the performance of the IC test in a real-world population: Sensitivity of the IC test at 24 months; Specificity of the IC test at 24 months; Negative predictive value of the IC test at 24 months	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

Secondary Outcome Measures

Outcome Measure	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.; 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.	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.	Up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess Test Performance in Sub-Populations	Assess the performance of the AAT and IC tests in patient subpopulations.; Sensitivity of the AAT test in patient sub-populations at 24 months; Specificity of the AAT test in patient sub-populations at 24 months; Positivity predictive value of the AAT in patient sub-populations test at 24 months; Sensitivity of the IC test in patient sub-populations at 24 months; Specificity of the IC test in patient sub-populations at 24 months; Negative predictive value of the IC test in patient sub-populations at 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.; Sensitivity of the AAT test in patient sub-populations at 24 months; Specificity of the AAT test in patient sub-populations at 24 months; Positivity predictive value of the AAT in patient sub-populations test at 24 months; Sensitivity of the IC test in patient sub-populations at 24 months; Specificity of the IC test in patient sub-populations at 24 months; Negative predictive value of the IC test in patient sub-populations at 24 months	Up to 24 months

Collaborators and Investigators

• Sponsor: Biodesix, Inc.
• Investigators: Principal Investigator: James Jett, MD, Biodesix, Inc.

Publications and helpful links

Helpful Links

• Sponsor website

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Lung nodule; Pulmonology
• Other Study ID Numbers: BDSX-CD-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No