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

An Observational Registry Study to Evaluate the Performance of the BDX-XL2 Test

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.

Study Overview

• Status: Active, not recruiting
• Conditions: NSCLC; Nodule Solitary Pulmonary

• Study Type: Observational
• Enrollment (Actual): 842

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Sun City, Arizona, United States, 85351
      • Banner Health
  • California
    • Northridge, California, United States, 91324
      • Amicis Research Center
  • Colorado
    • Pueblo, Colorado, United States, 81003
      • Pueblo Pulmonary Associates
  • Connecticut
    • Stamford, Connecticut, United States, 06904
      • Stamford Health
  • Florida
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research Center
  • Nevada
    • Las Vegas, Nevada, United States, 89154
      • University of Nevada, Las Vegas
  • North Carolina
    • Greenville, North Carolina, United States, 27858
      • East Carolina University
    • Pinehurst, North Carolina, United States, 28374
      • Pinehurst Medical Clinic
    • Winston-Salem, North Carolina, United States, 27103
      • Southeastern Research Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
  • Oregon
    • Portland, Oregon, United States, 97220
      • The Oregon Clinic
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Clinical Research Associates of Central PA/Penn Highlands Hospital
  • Washington
    • Bellingham, Washington, United States, 98225
      • PeaceHealth
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified from the patient populations of participating pulmonary medicine practices.

Description

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.
3. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Statistically significant change in the proportion of benign lung nodules managed by Nodify Lung experiencing invasive procedures.	Up to 2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BDX-CD-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No