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)

Biodesix

Status: Active, not recruiting

Conditions: Lung Nodules

Study type: Observational

Funder types: Industry

Identifiers

NCT06728319

BDSX-CD-011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.