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A Registry to Evaluate the Performance of the BDX-XL2 Test (ORACLE)

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ClinicalTrials.gov Identifier: NCT03766958
Recruitment Status : Enrolling by invitation
First Posted : December 6, 2018
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Biodesix, Inc.

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.

Condition or disease
Nodule Solitary Pulmonary NSCLC

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Registry Study to Evaluate the Performance of the BDX-XL2 Test
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort
Registry Patients With BDX-XL2 Results
Patients providing consent to have data collected to observe how BDX-XL2 results were used in the clinical management of their lung nodules.
Contemporaneous Group Without BDX-XL2
Contemporaneous group who did not have BDX-XL2 test results for use in the clinical management of their lung nodules.



Primary Outcome Measures :
  1. Statistically significant change in the proportion of benign lung nodules managed by BDX-XL2 experiencing invasive procedures. [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be identified from the patient populations of participating pulmonary medicine practices.
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 the BDX-XL2 test:

    • 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 50% or less.
  3. The first CT scan identifying the lung nodule of concern was performed within 3 months of patient enrollment in the registry. If beyond 3 months, a new CT within 3 months of patient enrollment must have been performed.

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. Current diagnosis of any active cancer.
  3. High risk per physician assessment.
  4. Prior diagnosis of any cancer within 2 years of lung nodule detection, except for non-melanoma skin cancer.
  5. Concurrent participation in any unrelated clinical trial that may impact or alter the management of the patient's nodule of concern.
  6. Any illness or factor that will prevent compliance with follow-up as recommended.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766958


Locations
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United States, Connecticut
The Stamford Hospital
Stamford, Connecticut, United States, 06904
United States, Nevada
University of Nevada, Las Vegas
Las Vegas, Nevada, United States, 89154
United States, North Carolina
Pinehurst Medical Clinic
Pinehurst, North Carolina, United States, 28374
Southeastern Research Center
Winston-Salem, North Carolina, United States, 27103
United States, Oregon
The Oregon Clinic
Portland, Oregon, United States, 97220
Sponsors and Collaborators
Biodesix, Inc.
Investigators
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Principal Investigator: Linda Traylor, PhD Biodesix, Inc.

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Responsible Party: Biodesix, Inc.
ClinicalTrials.gov Identifier: NCT03766958     History of Changes
Other Study ID Numbers: BDX-CD-002
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No