NCT03766958CompletedNot Applicable
An Observational Registry Study to Evaluate the Performance of the BDX-XL2 Test
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Biodesix, Inc.
- Enrollment
- 842
- Locations
- 15
- Primary Endpoint
- Statistically significant change in the proportion of benign lung nodules managed by Nodify Lung experiencing invasive procedures.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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.
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.
Outcomes
Primary Outcomes
Statistically significant change in the proportion of benign lung nodules managed by Nodify Lung experiencing invasive procedures.
Time Frame: Up to 2 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (15)
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