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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Registry Patients With Nodify Lung Results | Patients providing consent to have data collected to observe how Nodify Lung results were used in the clinical management of their lung nodules. | ||
| Contemporaneous Group Without Nodify Lung | Contemporaneous group who did not have Nodify Lung test results for use in the clinical management of their lung nodules. |
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| Measure | Description | Time Frame |
|---|---|---|
| Statistically significant change in the proportion of benign lung nodules managed by Nodify Lung experiencing invasive procedures. | Up to 2 years |
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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:
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Patients will be identified from the patient populations of participating pulmonary medicine practices.
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| Name | Affiliation | Role |
|---|---|---|
| Steve Springmeyer | Biodesix, Inc. | Principal Investigator |
| Michael Pritchett, DO | Pinehurst Medical Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Health | Sun City | Arizona | 85351 | United States | ||
| Amicis Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37432960 | Derived | Pritchett MA, Sigal B, Bowling MR, Kurman JS, Pitcher T, Springmeyer SC; ORACLE Study Investigators. Assessing a biomarker's ability to reduce invasive procedures in patients with benign lung nodules: Results from the ORACLE study. PLoS One. 2023 Jul 11;18(7):e0287409. doi: 10.1371/journal.pone.0287409. eCollection 2023. |
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| Northridge |
| California |
| 91324 |
| United States |
| Pueblo Pulmonary Associates | Pueblo | Colorado | 81003 | United States |
| Stamford Health | Stamford | Connecticut | 06904 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | United States |
| University of Nevada, Las Vegas | Las Vegas | Nevada | 89154 | United States |
| East Carolina University | Greenville | North Carolina | 27858 | United States |
| Pinehurst Medical Clinic | Pinehurst | North Carolina | 28374 | United States |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| The Oregon Clinic | Portland | Oregon | 97220 | United States |
| Clinical Research Associates of Central PA/Penn Highlands Hospital | DuBois | Pennsylvania | 15801 | United States |
| Peacehealth | Bellingham | Washington | 98225 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D003074 | Solitary Pulmonary Nodule |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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