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

NSCLC Clinical Trial

— ORACLE  

Official title:

An Observational Registry Study to Evaluate the Performance of the BDX-XL2 Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766958
• Other study ID #: BDX-CD-002
• Status: Completed
• Start date: October 16, 2018
• Est. completion date: May 23, 2024

Study information

• Verified date: May 2024
• Source: Biodesix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 842
• Est. completion date: May 23, 2024
• Est. primary completion date: May 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Patient has provided informed consent to participate in the registry and agrees to comply with all protocol requirements.

2. 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.

3. The first CT scan identifying the lung nodule of concern was performed within 60 days of patient enrollment in the registry.

Exclusion Criteria:

1. 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.

2. High risk per physician assessment (i.e. > 65% by physician pCA)

3. Current diagnosis of any active cancer.

4. Prior diagnosis of lung cancer.

5. Prior diagnosis of any cancer within 5 years of lung nodule detection, except for non-melanomatous skin cancer.

6. Concurrent participation in any unrelated clinical trial that may impact or alter the management of the patient's nodule of concern.

7. Any illness or factor that will prevent compliance with follow-up as recommended.

Related Conditions & MeSH terms

• Nodule Solitary Pulmonary
• NSCLC

Locations

Country	Name	City	State
United States	Peacehealth	Bellingham	Washington
United States	University of Cincinnati	Cincinnati	Ohio
United States	Clinical Research Associates of Central PA/Penn Highlands Hospital	DuBois	Pennsylvania
United States	Parkview Research Center	Fort Wayne	Indiana
United States	East Carolina University	Greenville	North Carolina
United States	University of Nevada, Las Vegas	Las Vegas	Nevada
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Amicis Research Center	Northridge	California
United States	Pinehurst Medical Clinic	Pinehurst	North Carolina
United States	The Oregon Clinic	Portland	Oregon
United States	Pueblo Pulmonary Associates	Pueblo	Colorado
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Stamford Health	Stamford	Connecticut
United States	Banner Health	Sun City	Arizona
United States	Southeastern Research Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Biodesix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Statistically significant change in the proportion of benign lung nodules managed by Nodify Lung experiencing invasive procedures.		Up to 2 years