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ACTIVE NOT RECRUITING
NCT04171492

Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules

Sponsor: Biodesix, Inc.

View on ClinicalTrials.gov

Summary

This study evaluates the how addition of the Nodify XL2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer.

Official title: A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2020-12-18

Completion Date

2026-12

Last Updated

2025-09-19

Healthy Volunteers

Not specified

Locations (25)

University of Colorado

Aurora, Colorado, United States

Massachusetts General Hospital

Boston, Connecticut, United States

Beth Israel Deaconess

Boston, Connecticut, United States

MedStar

Washington D.C., District of Columbia, United States

Indiana University

Indianapolis, Indiana, United States

The Johns Hopkins University

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

The Washington University

St Louis, Missouri, United States

Mount Sinai Health System

New York, New York, United States

Northwell Health

New York, New York, United States

The University of North Carolina

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

Southeastern Research Center

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Coulmbus, Ohio, United States

The Oregon Clinic

Portland, Oregon, United States

Ralph H Johnson VA Medical Center

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Prisma Health

Greenville, South Carolina, United States

University of Texas Southwestern

Dallas, Texas, United States

University of Texas Medical Branch

Galveston, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

University of Calgary

Calgary, Alberta, Canada

McGill University Health Centre

Montreal, Quebec, Canada