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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-small Cell Carcinoma; Nodule Solitary Pulmonary

Detailed Description

A multicenter, randomized controlled study with a blinded control arm. Open label arm is observational 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 newly identified solid lung nodules assessed as < 50% risk of cancer by Mayo risk prediction algorithm.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2W 1S7
      • University of Calgary
  • Quebec
    • Montreal, Quebec, Canada, H3H 2R9
      • McGill University Health Centre
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Connecticut
    • Boston, Connecticut, United States, 02114
      • Massachusetts General Hospital
    • Boston, Connecticut, United States, 02215
      • Beth Israel Deaconess
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • The Johns Hopkins University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • St Louis, Missouri, United States, 63110
      • The Washington University
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Health System
    • New York, New York, United States, 11042
      • Northwell Health
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • The University of North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University
    • Winston-Salem, North Carolina, United States, 27103
      • Southeastern Research Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Coulmbus, Ohio, United States, 43210
      • The Ohio State University
  • Oregon
    • Portland, Oregon, United States, 97220
      • The Oregon Clinic
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Charleston, South Carolina, United States, 29401
      • Ralph H Johnson VA Medical Center
    • Greenville, South Carolina, United States, 29605
      • Prisma Health
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Biodesix, Inc.
• Investigators: Principal Investigator: Gerard Silvestri, MD, Medical University of South Carolina; Principal Investigator: Steven Springmeyer, Biodesix, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Solitary Pulmonary Nodule
• Other Study ID Numbers: BDX-CD-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No