A Registry to Evaluate the Performance of the BDX-XL2 Test
NCT ID: NCT03766958
Last Updated: 2024-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
842 participants
OBSERVATIONAL
2018-10-16
2024-05-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
ALL
No
Sponsors
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Biodesix, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Steve Springmeyer
Role: PRINCIPAL_INVESTIGATOR
Biodesix, Inc.
Michael Pritchett, DO
Role: PRINCIPAL_INVESTIGATOR
Pinehurst Medical Clinic
Locations
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Banner Health
Sun City, Arizona, United States
Amicis Research Center
Northridge, California, United States
Pueblo Pulmonary Associates
Pueblo, Colorado, United States
Stamford Health
Stamford, Connecticut, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Parkview Research Center
Fort Wayne, Indiana, United States
University of Nevada, Las Vegas
Las Vegas, Nevada, United States
East Carolina University
Greenville, North Carolina, United States
Pinehurst Medical Clinic
Pinehurst, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Oregon Clinic
Portland, Oregon, United States
Clinical Research Associates of Central PA/Penn Highlands Hospital
DuBois, Pennsylvania, United States
Peacehealth
Bellingham, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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BDX-CD-002
Identifier Type: -
Identifier Source: org_study_id
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