Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules
NCT ID: NCT04171492
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
2000 participants
OBSERVATIONAL
2020-12-18
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Open Label
Nodify XL2 results will be reported to the investigator and available to the subject.
No interventions assigned to this group
Blinded
Nodify XL2 results will not be available to the investigative site or subject.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Subject is \> 40 years of age at the time of the discovery of the lung nodule of concern
3. 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
4. The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment
5. The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less
Exclusion Criteria
2. Nodule of concern is part-solid or Ground Glass Opacity (GGO)
3. Prior diagnosis of lung cancer
4. Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer
5. Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment
6. Concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern
7. Any illness or factor that will inhibit compliance with study participation
40 Years
ALL
No
Sponsors
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Biodesix, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Springmeyer
Role: PRINCIPAL_INVESTIGATOR
Biodesix, Inc.
Gerard Silvestri, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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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
Countries
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Other Identifiers
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BDX-CD-003
Identifier Type: -
Identifier Source: org_study_id
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