Clinical trial 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Nodules
Keywords: Lung nodule
Pulmonology
Lead sponsor: Biodesix, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-11
Enrollment: 4000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Assess Test Performance of AAT test
timeFrame: Up to 24 months
measure: Assess Test Performance of IC test
timeFrame: 24 months
measure: Assess serial performance of serial testing with the AAC and IC tests.
timeFrame: 24 months
Secondary outcomes:
measure: Assess ATT Test Accuracy
timeFrame: Up to 24 months
measure: Determine Health Outcomes
timeFrame: Up to 24 months
Other outcomes:
measure: Assess Test Performance in Sub-Populations
timeFrame: Up to 24 months
measure: Assess Test Performance in Populations Outside of Validation
timeFrame: Up to 24 months
Locations:
city: Brandon
country: United States
facility: Pulmonary & Sleep of Tampa Bay
state: Florida
city: Fort Walton Beach
country: United States
facility: White-Wilson Medical Center
state: Florida
city: Somerset
country: United States
facility: The Lung and Sleep Disorder Institute
state: Kentucky
city: Fairhaven
country: United States
facility: Southcoast Health System
state: Massachusetts
city: DuBois
country: United States
facility: The Lung Center, PC
state: Pennsylvania
Study officials:
affiliation: Biodesix, Inc.
name: James Jett, MD
role: PRINCIPAL_INVESTIGATOR
References: