A Registry to Evaluate the Performance of the BDX-XL2 Test

ClinicalTrials.gov ID: NCT03766958

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.

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ClinicalTrials.gov public records Last synced Oct 23, 2026, 8:41 AM EDT

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
Lead sponsor: Biodesix, Inc.; Industry
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 16, 2018 (Actual)
Primary completion: May 12, 2022 (Actual)
Completion: May 23, 2024 (Actual)
Last update posted: May 24, 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 24, 2024 · Synced Oct 23, 2026

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The complete public registry record, listed eligibility criteria, and available contact information for NCT03766958 live on ClinicalTrials.gov.

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