Trials / Completed
CompletedNCT03766958
A Registry to Evaluate the Performance of the BDX-XL2 Test
An Observational Registry Study to Evaluate the Performance of the BDX-XL2 Test
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 842 (actual)
- Sponsor
- Biodesix, Inc. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2018-10-16
- Primary completion
- 2022-05-12
- Completion
- 2024-05-23
- First posted
- 2018-12-06
- Last updated
- 2024-05-24
Locations
15 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03766958. Inclusion in this directory is not an endorsement.