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

NCT06728319 | Active Not Recruiting

• 1 other identifier: BDSX-CD-011
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Lung Nodules

Keywords

Lung nodule; Pulmonology

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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 Outcomes (2)

• Assess ATT Test Accuracy

  Up to 24 months

• Determine Health Outcomes

  Up to 24 months

Other Outcomes (2)

• Assess Test Performance in Sub-Populations

  Up to 24 months

• Assess Test Performance in Populations Outside of Validation

  Up to 24 months

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Biodesix, Inc.: lead

Study Sites (5)

Pulmonary & Sleep of Tampa Bay

Brandon, Florida, 33511, United States

Location

White-Wilson Medical Center

Fort Walton Beach, Florida, 32548, United States

Location

The Lung and Sleep Disorder Institute

Somerset, Kentucky, 42503, United States

Location

Southcoast Health System

Fairhaven, Massachusetts, 02720, United States

Location

The Lung Center, PC

DuBois, Pennsylvania, 15801, United States

Location

Related Links

• Sponsor website

Study Officials

• James Jett, MD

  Biodesix, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: December 11, 2024
• Study Start: September 19, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)