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

C
Catherine Sears, MD

Primary Investigator

Overview

This study evaluates the how addition of the Nodify XL2 test result impacts the clinicalgement of newly identified solid lung nodules assessed as low to moderate risk of cancer.

Description

A multicenter, randomized controlled study with a blinded control arm. Open label arm isbservational for lung nodule management. The clinical trial will evaluate the clinical utility of the Nodify XL2 integrated classifier when used in the clinical management of newlydentified solid lung nodules assessed as < 50% risk of cancer by Mayo risk predictiongorithm.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Nodule Solitary Pulmonary, Non-small Cell Carcinoma
  • Age: 40 Years
  • Gender: All

Inclusion Criteria:
  1. Subject has provided informed consent to participate in the study and agrees to complywith all protocol requirements
  2. Subject is > 40 years of age at the time of the discovery of the lung nodule of
  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%
Exclusion Criteria:
  1. Nodule work-up at the time of subject enrollment indicating any prior attempted ord diagnostic biopsy procedure or blood-based testing for the lung nodule of
  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 ofkin cancer
  5. Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or) within 30 days of subject enrollment
  6. Concurrent participation in any unrelated clinical trial that may impact or alter thegement of the subject's nodule of concern
  7. Any illness or factor that will inhibit compliance with study participation

Updated on 29 Apr 2024. Study ID: BDX-CD-003
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