Status:
COMPLETED
A Registry to Evaluate the Performance of the BDX-XL2 Test
Lead Sponsor:
Biodesix, Inc.
Conditions:
Nodule Solitary Pulmonary
NSCLC
Eligibility:
All Genders
40+ years
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 ben...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 16 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 23 2024
Estimated Enrollment :
842 Patients enrolled
Trial Details
Trial ID
NCT03766958
Start Date
October 16 2018
End Date
May 23 2024
Last Update
May 24 2024
Active Locations (15)
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1
Banner Health
Sun City, Arizona, United States, 85351
2
Amicis Research Center
Northridge, California, United States, 91324
3
Pueblo Pulmonary Associates
Pueblo, Colorado, United States, 81003
4
Stamford Health
Stamford, Connecticut, United States, 06904