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



Status:Enrolling by invitation
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - Any
Updated:1/23/2019
Start Date:October 16, 2018
End Date:December 2020

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

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.


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.
We found this trial at
5
sites
Portland, Oregon 97210
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Portland, OR
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Las Vegas, Nevada 89154
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Las Vegas, NV
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Pinehurst, North Carolina 28734
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Pinehurst, NC
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Stamford, Connecticut 06904
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Stamford, CT
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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