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

Completed

Conditions studied: Nodule Solitary Pulmonary, NSCLC

In brief

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.

Key facts

Study ID

NCT03766958

Run by

Biodesix, Inc.

People needed

842

Starts

2018-10-16

Expected to finish

2024-05-23

Last updated by the study team

2024-05-24

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Banner Health — Sun City, Arizona, United States
• Amicis Research Center — Northridge, California, 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
• Southeastern Research Center — Winston-Salem, 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
• Peacehealth — Bellingham, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.