Clincosm LogoSign in Get a demo

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

Sponsor
Biodesix, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04171492
Collaborator
(none)
2,000
Enrollment
17
Locations
47.4
Anticipated Duration (Months)
117.6
Patients Per Site
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the how addition of the Nodify XL2 test result impacts the clinical management of new, incidentally identified solid lung nodules assessed as low to moderate risk of cancer.

Condition or Disease Intervention/Treatment Phase

    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 new, incidentally identified solid lung nodules assessed as < 50% risk of cancer by Mayo risk prediction algorithm.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    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
    Actual Study Start Date :
    Dec 18, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Lung Nodule Diagnosis [Up to 24 months]

      Malignant diagnosis through histology/pathology or benign diagnosis through histology/pathology, radiologic stability or radiologic confirmation of nodule resolution

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    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

    • Is a solid nodule

    • Has maximal dimension of > 8mm and < 30mm

    1. The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment

    2. The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 50% or less

    Exclusion Criteria:

    1. Nodule work-up at the time of subject enrollment indicating any prior attempted or completed diagnostic biopsy procedure for the lung nodule of concern

    2. Nodule of concern is part-solid or Ground Glass Opacity (GGO)

    3. Nodule of concern was detected during lung cancer screening

    4. Prior diagnosis of lung cancer

    5. Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer

    6. Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment

    7. Concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern

    8. Any illness or factor that will inhibit compliance with study participation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Aurora Colorado United States 80045
    2 National Jewish Health Denver Colorado United States 80206
    3 MedStar Washington District of Columbia United States 20010
    4 The Johns Hopkins University Baltimore Maryland United States 21205
    5 University of Michigan Ann Arbor Michigan United States 48109
    6 Mayo Clinic Rochester Minnesota United States 55905
    7 The Washington University Saint Louis Missouri United States 63110
    8 Northwell Health New York New York United States 11042
    9 The University of North Carolina Chapel Hill North Carolina United States 27599
    10 Duke University Durham North Carolina United States 27705
    11 Cleveland Clinic Cleveland Ohio United States 44195
    12 Ralph H Johnson VA Medical Center Charleston South Carolina United States 29401
    13 Medical University of South Carolina Charleston South Carolina United States 29425
    14 University of Texas Medical Branch Galveston Texas United States 77555
    15 Virginia Commonwealth University Richmond Virginia United States 23219
    16 University of Calgary Calgary Alberta Canada T2W 1S7
    17 McGill University Health Centre Montréal Quebec Canada H3H 2R9

    Sponsors and Collaborators

    • Biodesix, Inc.

    Investigators

    • Principal Investigator: Linda Traylor, PhD, Biodesix, Inc.
    • Principal Investigator: Gerard Silvestri, MD, Medical University of South Carolina

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biodesix, Inc.
    ClinicalTrials.gov Identifier:
    NCT04171492
    Other Study ID Numbers:
    • BDX-CD-003
    First Posted:
    Nov 21, 2019
    Last Update Posted:
    Oct 18, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 18, 2021