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

Running, not enrolling

Conditions studied: Nodule Solitary Pulmonary, Non-small Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT04171492

Run by

Biodesix, Inc.

People needed

2000

Starts

2020-12-18

Expected to finish

2026-12-01

Last updated by the study team

2025-09-19

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements
• Subject is > 40 years of age at the time of the discovery of the lung nodule of concern
• Subject's lung nodule of concern meets the following:
• Was incidentally identified or detected during lung cancer screening
• Is a solid nodule
• Has maximal dimension of > 8mm and < 30mm
• The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment
• The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less

You may not qualify if…

• Nodule work-up at the time of subject enrollment indicating any prior attempted or completed diagnostic biopsy procedure or blood-based testing for the lung nodule of concern
• Nodule of concern is part-solid or Ground Glass Opacity (GGO)
• Prior diagnosis of lung cancer
• Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer
• Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment
• Concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern
• Any illness or factor that will inhibit compliance with study participation

Where it is running

• 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

Full record on ClinicalTrials.gov

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