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

NCT04171492 | Active Not Recruiting

• 1 other identifier: BDX-CD-003
• Study Type: observational
• Target: 2,000
• Locations: 2 countries
• Sites: 25

Brief 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.

Conditions

Nodule Solitary Pulmonary; Non-small Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Lung Nodule Diagnosis

  Malignant diagnosis through histology/pathology or benign diagnosis through histology/pathology, radiologic stability or radiologic confirmation of nodule resolution

  Up to 24 months

Study Arms (2)

Open Label

Nodify XL2 results will be reported to the investigator and available to the subject.

Blinded

Nodify XL2 results will not be available to the investigative site or subject.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with newly identified, solid lung nodule determined to be low-moderate risk of cancer.

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

Sponsors & Collaborators

• Biodesix, Inc.: lead

Study Sites (25)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Massachusetts General Hospital

Boston, Connecticut, 02114, United States

Location

Beth Israel Deaconess

Boston, Connecticut, 02215, United States

Location

MedStar

Washington D.C., District of Columbia, 20010, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

The Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Washington University

St Louis, Missouri, 63110, United States

Location

Mount Sinai Health System

New York, New York, 10029, United States

Location

Northwell Health

New York, New York, 11042, United States

Location

The University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Coulmbus, Ohio, 43210, United States

Location

The Oregon Clinic

Portland, Oregon, 97220, United States

Location

Ralph H Johnson VA Medical Center

Charleston, South Carolina, 29401, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health

Greenville, South Carolina, 29605, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

University of Calgary

Calgary, Alberta, T2W 1S7, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3H 2R9, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nodify XL2 plasma sample

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Steven Springmeyer

  Biodesix, Inc.

  PRINCIPAL INVESTIGATOR

• Gerard Silvestri, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: December 18, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

US (23); CA (2)