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

Biodesix

Status: Completed

Conditions: Nodule Solitary Pulmonary; NSCLC

Study type: Observational

Funder types: Industry

Identifiers

NCT03766958

BDX-CD-002

Details and patient eligibility

About

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.

Enrollment: 842 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

842 participants in 2 patient groups

Registry Patients With Nodify Lung Results

Description:

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

Description:

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