A Registry to Evaluate the Performance of the BDX-XL2 Test
Public ClinicalTrials.gov record NCT03766958. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Observational Registry Study to Evaluate the Performance of the BDX-XL2 Test
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03766958
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 842 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 15, 2018
- Primary completion
- May 11, 2022
- Completion
- May 22, 2024
- Last update posted
- May 23, 2024
2018 – 2024
United States locations
- U.S. sites
- 15
- U.S. states
- 13
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Health | Sun City | Arizona | 85351 | — |
| Amicis Research Center | Northridge | California | 91324 | — |
| Pueblo Pulmonary Associates | Pueblo | Colorado | 81003 | — |
| Stamford Health | Stamford | Connecticut | 06904 | — |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | — |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | — |
| University of Nevada, Las Vegas | Las Vegas | Nevada | 89154 | — |
| East Carolina University | Greenville | North Carolina | 27858 | — |
| Pinehurst Medical Clinic | Pinehurst | North Carolina | 28374 | — |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| The Oregon Clinic | Portland | Oregon | 97220 | — |
| Clinical Research Associates of Central PA/Penn Highlands Hospital | DuBois | Pennsylvania | 15801 | — |
| Peacehealth | Bellingham | Washington | 98225 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03766958, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 23, 2024 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03766958 live on ClinicalTrials.gov.