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

Completed

• Conditions: Nodule Solitary Pulmonary; NSCLC

• Registration Number: NCT03766958
• Lead Sponsor: Biodesix, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-16
• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-06
• Primary Completion: 2022-05-12
• Status Verified: 2024-05
• Study Completion: 2024-05-23
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 842

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (15)

Southeastern Research Center; 🇺🇸 Winston-Salem, North Carolina, United States

Peacehealth; 🇺🇸 Bellingham, Washington, United States

Amicis Research Center; 🇺🇸 Northridge, California, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Banner Health; 🇺🇸 Sun City, Arizona, United States

Pueblo Pulmonary Associates; 🇺🇸 Pueblo, Colorado, United States

Stamford Health; 🇺🇸 Stamford, Connecticut, United States

Sarasota Memorial Hospital; 🇺🇸 Sarasota, Florida, United States

Parkview Research Center; 🇺🇸 Fort Wayne, Indiana, United States

University of Nevada, Las Vegas; 🇺🇸 Las Vegas, Nevada, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

Pinehurst Medical Clinic; 🇺🇸 Pinehurst, North Carolina, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

The Oregon Clinic; 🇺🇸 Portland, Oregon, United States

Clinical Research Associates of Central PA/Penn Highlands Hospital; 🇺🇸 DuBois, Pennsylvania, United States