CompletedNot Applicable

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

United States842 participantsStarted 2018-10-16

Plain-language 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.

Who can participate

Age range40 Years

SexALL

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Inclusion criteria

✓. 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:
✓. The first CT scan identifying the lung nodule of concern was performed within 60 days of patient enrollment in the registry.

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: Up to 2 years

Trial details

NCT IDNCT03766958

SponsorBiodesix, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-05-12

View on ClinicalTrials.gov More Nodule Solitary Pulmonary trials