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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Nodule Solitary Pulmonary
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

Denver

National Jewish Health, Denver, Colorado, United States, 80206

Boston

Massachusetts General Hospital, Boston, Connecticut, United States, 02114

Boston

Beth Israel Deaconess, Boston, Connecticut, United States, 02215

Washington

MedStar, Washington, District of Columbia, United States, 20010

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202

Baltimore

The Johns Hopkins University, Baltimore, Maryland, United States, 21205

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Saint Louis

The Washington University, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Biodesix, Inc.,

Steven Springmeyer, PRINCIPAL_INVESTIGATOR, Biodesix, Inc.

Gerard Silvestri, MD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

2026-12