Clinical trial NCT03766958: A Registry to Evaluate the Performance of the BDX-XL2 Test
Official title: An Observational Registry Study to Evaluate the Performance of the BDX-XL2 Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nodule Solitary Pulmonary
NSCLC
Lead sponsor: Biodesix, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-06
Enrollment: 842
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be identified from the patient populations of participating pulmonary medicine practices.

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Statistically significant change in the proportion of benign lung nodules managed by Nodify Lung experiencing invasive procedures.
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Banner Health
state: Arizona
city: Northridge
country: United States
facility: Amicis Research Center
state: California
city: Pueblo
country: United States
facility: Pueblo Pulmonary Associates
state: Colorado
city: Stamford
country: United States
facility: Stamford Health
state: Connecticut
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Las Vegas
country: United States
facility: University of Nevada, Las Vegas
state: Nevada
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Medical Clinic
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: DuBois
country: United States
facility: Clinical Research Associates of Central PA/Penn Highlands Hospital
state: Pennsylvania
city: Bellingham
country: United States
facility: Peacehealth
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Biodesix, Inc.
name: Steve Springmeyer
role: PRINCIPAL_INVESTIGATOR
affiliation: Pinehurst Medical Clinic
name: Michael Pritchett, DO
role: PRINCIPAL_INVESTIGATOR
References: