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

February 6, 2024 updated by: Biodesix, Inc.

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

Recruiting

Conditions

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2W 1S7
        • Recruiting
        • University of Calgary
        • Contact:
          • Rommy Koetzler, MD, PhD
        • Principal Investigator:
          • Alain Tremblay, MD
    • Quebec
      • Montréal, Quebec, Canada, H3H 2R9
        • Recruiting
        • McGill University Health Centre
        • Contact:
          • Irina Uscatescu
        • Principal Investigator:
          • Anne Gonzalez, MD
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Contact:
          • Natalie Johnson
        • Principal Investigator:
          • Nina Thomas, MD
      • Denver, Colorado, United States, 80206
        • Withdrawn
        • National Jewish Health
    • Connecticut
      • Boston, Connecticut, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Kethia Decius
        • Principal Investigator:
          • Fayez Kheir, MD
      • Boston, Connecticut, United States, 02215
        • Recruiting
        • Beth Israel Deaconess
        • Contact:
          • Chrissy Conley
        • Principal Investigator:
          • Mihir Parikh, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Medstar
        • Contact:
          • Claire Centeno
        • Principal Investigator:
          • Jessica Wang Memoli, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
          • Ahmad Karkash, MD
        • Principal Investigator:
          • Catherine Sears, MD
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • The Johns Hopkins University
        • Contact:
          • Jenna Los
        • Principal Investigator:
          • Lonny Yarmus, DO
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
          • Catherine Meldrum, PhD
        • Principal Investigator:
          • Doug Arenberg, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Brandon Clapp
        • Principal Investigator:
          • David Midthun, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • The Washington University
        • Principal Investigator:
          • Alexander Chen, MD
        • Contact:
          • Emily Harrison
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Health System
        • Contact:
        • Principal Investigator:
          • Dr. Javier Zulueta
      • New York, New York, United States, 11042
        • Recruiting
        • Northwell Health
        • Contact:
          • Zarnab Naqvi
        • Principal Investigator:
          • Suhail Raoof, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • The University of North Carolina
        • Contact:
          • Jackson Pettee
        • Principal Investigator:
          • Cole Burks, MD
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University
        • Principal Investigator:
          • Momen Wahidi, MD
        • Contact:
          • Kathleen Coles
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Southeastern Research Center
        • Contact:
          • Karen McCutcheon
        • Principal Investigator:
          • Benjamin Bregman, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Smith Brian
        • Principal Investigator:
          • Peter Mazzone, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Principal Investigator:
          • Nicholas Pastis, MD
        • Contact:
          • Michael Woods
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
          • Michael Balassone
        • Principal Investigator:
          • Gerard Silvestri, MD
      • Charleston, South Carolina, United States, 29401
        • Recruiting
        • Ralph H Johnson VA Medical Center
        • Contact:
          • Joseph Roberts
        • Principal Investigator:
          • Nichole Tanner, MD
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health
        • Contact:
          • Allie Watts, BSN
        • Principal Investigator:
          • Sean Callahan, MD
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern
        • Principal Investigator:
          • Muhanned Abu-Hijleh, MD
        • Contact:
          • Reagan Volzer
      • Galveston, Texas, United States, 77555
        • Recruiting
        • University of Texas Medical Branch
        • Contact:
          • Cindy Mitchell
        • Principal Investigator:
          • Shawn Nishi, MD
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
          • Amy Frayser
        • Principal Investigator:
          • Patrick Nana-Sinkam, MD

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.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: Up to 24 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Biodesix, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2020

Primary Completion (Estimated)

December 1, 2024

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)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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