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Clinical Trials in Canada / NCT04171492
Active, not recruiting Observational

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

NCT04171492 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2020-12-18
Last updated
2025-09-19

Condition(s) studied

Nodule Solitary PulmonaryNon-small Cell Carcinoma

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements 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: 1. 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 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

Primary outcome measure(s)

Trial sites (25)

FacilityCityRegionStatus
University of Colorado Aurora Colorado
Massachusetts General Hospital Boston Connecticut
Beth Israel Deaconess Boston Connecticut
MedStar Washington D.C. District of Columbia
Indiana University Indianapolis Indiana
The Johns Hopkins University Baltimore Maryland
University of Michigan Ann Arbor Michigan
Mayo Clinic Rochester Minnesota
The Washington University St Louis Missouri
Mount Sinai Health System New York New York
Northwell Health New York New York
The University of North Carolina Chapel Hill North Carolina
Duke University Durham North Carolina
Southeastern Research Center Winston-Salem North Carolina
Cleveland Clinic Cleveland Ohio
The Ohio State University Coulmbus Ohio
The Oregon Clinic Portland Oregon
Ralph H Johnson VA Medical Center Charleston South Carolina
Medical University of South Carolina Charleston South Carolina
Prisma Health Greenville South Carolina
University of Texas Southwestern Dallas Texas
University of Texas Medical Branch Galveston Texas
Virginia Commonwealth University Richmond Virginia
University of Calgary Calgary Alberta
McGill University Health Centre Montreal Quebec

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04171492 on ClinicalTrials.gov ↗ ← All trials in Canada