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NCT Number: NCT06728319

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Lung Nodules

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pulmonary & Sleep of Tampa Bay, Brandon, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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:

    • 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

  2. Assess Test Performance of IC test

    Time frame: 24 months

    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

  3. 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

Secondary outcomes

  1. Assess ATT Test Accuracy

    Time frame: 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.

  2. Determine Health Outcomes

    Time frame: 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.

Other outcomes

  1. Assess Test Performance in Sub-Populations

    Time frame: Up to 24 months

    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

  2. Assess Test Performance in Populations Outside of Validation

    Time frame: Up to 24 months

    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

Sponsors and collaborators

Lead sponsor

Biodesix, Inc.

Industry

Registry information

Acronym: CLARIFY

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 11, 2024
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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