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ORACLE: A Registry to Evaluate the Performance of the BDX-XL2 Test

Sponsor
Biodesix, Inc. (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03766958
Collaborator
(none)
1,250
Enrollment
15
Locations
61.5
Anticipated Duration (Months)
83.3
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the ORACLE Registry is to demonstrate clinical utility of the BDX-XL2 test; specifically, the potential to reduce unnecessary invasive procedures, such as biopsies and surgeries, on benign lung nodules while not significantly increasing the number of malignant lung nodules routed to CT surveillance. Clinical data will be collected from participating patients to evaluate the impact of the BDX-XL2 test when used in the clinical management of recently identified lung nodules assessed to have a low to moderate risk of cancer.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An Observational Registry Study to Evaluate the Performance of the BDX-XL2 Test
    Actual Study Start Date :
    Oct 16, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Registry Patients With Nodify Lung Results

    Patients providing consent to have data collected to observe how Nodify Lung results were used in the clinical management of their lung nodules.
    Contemporaneous Group Without Nodify Lung

    Contemporaneous group who did not have Nodify Lung test results for use in the clinical management of their lung nodules.

    Outcome Measures

    Primary Outcome Measures

    1. Statistically significant change in the proportion of benign lung nodules managed by Nodify Lung experiencing invasive procedures. [Up to 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patient has provided informed consent to participate in the registry and agrees to comply with all protocol requirements.

    2. Patient meets the criteria for the intended use population of Nodify Lung testing:

    • Patient is > 40 years of age at the time of the discovery of the lung nodule of concern.

    • The maximal dimension of the patient's lung nodule of concern is > 8mm and < 30mm.

    • The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less.

    1. The first CT scan identifying the lung nodule of concern was performed within 60 days of patient enrollment in the registry.
    Exclusion Criteria:

    1. Nodule work-up before the time of patient enrollment indicating any attempted or completed biopsy procedure after the first CT scan identifying the lung nodule of concern.

    2. High risk per physician assessment (i.e. > 65% by physician pCA)

    3. Current diagnosis of any active cancer.

    4. Prior diagnosis of lung cancer.

    5. Prior diagnosis of any cancer within 5 years of lung nodule detection, except for non-melanomatous skin cancer.

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

    7. Any illness or factor that will prevent compliance with follow-up as recommended.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner Health Sun City Arizona United States 85351
    2 Amicis Research Center Northridge California United States 91324
    3 Pueblo Pulmonary Associates Pueblo Colorado United States 81003
    4 Stamford Health Stamford Connecticut United States 06904
    5 Sarasota Memorial Hospital Sarasota Florida United States 34239
    6 Parkview Research Center Fort Wayne Indiana United States 46845
    7 University of Nevada, Las Vegas Las Vegas Nevada United States 89154
    8 East Carolina University Greenville North Carolina United States 27858
    9 Pinehurst Medical Clinic Pinehurst North Carolina United States 28374
    10 Southeastern Research Center Winston-Salem North Carolina United States 27103
    11 University of Cincinnati Cincinnati Ohio United States 45267
    12 The Oregon Clinic Portland Oregon United States 97220
    13 Clinical Research Associates of Central PA/Penn Highlands Hospital DuBois Pennsylvania United States 15801
    14 Peacehealth Bellingham Washington United States 98225
    15 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Biodesix, Inc.

    Investigators

    • Principal Investigator: Leona Hamrick, DHSc, PA-C, MSL-BC, Biodesix, Inc.
    • Principal Investigator: Michael Pritchett, DO, Pinehurst Medical Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biodesix, Inc.
    ClinicalTrials.gov Identifier:
    NCT03766958
    Other Study ID Numbers:
    • BDX-CD-002
    First Posted:
    Dec 6, 2018
    Last Update Posted:
    Mar 16, 2022
    Last Verified:
    Mar 1, 2022
    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 Mar 16, 2022