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

NCT03766958 | Completed

• 1 other identifier: BDX-CD-002
• Study Type: observational
• Target: 842
• Locations: 1 country
• Sites: 15

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.

Conditions

Nodule Solitary Pulmonary; NSCLC

Outcome Measures

Primary Outcomes (1)

• Statistically significant change in the proportion of benign lung nodules managed by Nodify Lung experiencing invasive procedures.

  Up to 2 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patient has provided informed consent to participate in the registry and agrees to comply with all protocol requirements.
• 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.
• The first CT scan identifying the lung nodule of concern was performed within 60 days of patient enrollment in the registry.

You may not qualify if:

• 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.
• High risk per physician assessment (i.e. \> 65% by physician pCA)
• Current diagnosis of any active cancer.
• Prior diagnosis of lung cancer.
• Prior diagnosis of any cancer within 5 years of lung nodule detection, except for non-melanomatous skin cancer.
• Concurrent participation in any unrelated clinical trial that may impact or alter the management of the patient's nodule of concern.
• Any illness or factor that will prevent compliance with follow-up as recommended.

Sponsors & Collaborators

• Biodesix, Inc.: lead

Study Sites (15)

Banner Health

Sun City, Arizona, 85351, United States

Location

Amicis Research Center

Northridge, California, 91324, United States

Location

Pueblo Pulmonary Associates

Pueblo, Colorado, 81003, United States

Location

Stamford Health

Stamford, Connecticut, 06904, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Parkview Research Center

Fort Wayne, Indiana, 46845, United States

Location

University of Nevada, Las Vegas

Las Vegas, Nevada, 89154, United States

Location

East Carolina University

Greenville, North Carolina, 27858, United States

Location

Pinehurst Medical Clinic

Pinehurst, North Carolina, 28374, United States

Location

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

The Oregon Clinic

Portland, Oregon, 97220, United States

Location

Clinical Research Associates of Central PA/Penn Highlands Hospital

DuBois, Pennsylvania, 15801, United States

Location

Peacehealth

Bellingham, Washington, 98225, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Pritchett MA, Sigal B, Bowling MR, Kurman JS, Pitcher T, Springmeyer SC; ORACLE Study Investigators. Assessing a biomarker's ability to reduce invasive procedures in patients with benign lung nodules: Results from the ORACLE study. PLoS One. 2023 Jul 11;18(7):e0287409. doi: 10.1371/journal.pone.0287409. eCollection 2023.

  PMID: 37432960 DERIVED

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Steve Springmeyer

  Biodesix, Inc.

  PRINCIPAL INVESTIGATOR

• Michael Pritchett, DO

  Pinehurst Medical Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 6, 2018
• Study Start: October 16, 2018
• Primary Completion: May 12, 2022
• Study Completion: May 23, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

US (15)