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

May 23, 2024 updated by: Biodesix, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
842

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Banner Health
    • California
      • Northridge, California, United States, 91324
        • Amicis Research Center
    • Colorado
      • Pueblo, Colorado, United States, 81003
        • Pueblo Pulmonary Associates
    • Connecticut
      • Stamford, Connecticut, United States, 06904
        • Stamford Health
    • Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Research Center
    • Nevada
      • Las Vegas, Nevada, United States, 89154
        • University of Nevada, Las Vegas
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • East Carolina University
      • Pinehurst, North Carolina, United States, 28374
        • Pinehurst Medical Clinic
      • Winston-Salem, North Carolina, United States, 27103
        • Southeastern Research Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Oregon
      • Portland, Oregon, United States, 97220
        • The Oregon Clinic
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Clinical Research Associates of Central PA/Penn Highlands Hospital
    • Washington
      • Bellingham, Washington, United States, 98225
        • PeaceHealth
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be identified from the patient populations of participating pulmonary medicine practices.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Statistically significant change in the proportion of benign lung nodules managed by Nodify Lung experiencing invasive procedures.
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biodesix, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Pritchett, DO, Pinehurst Medical Clinic
  • Principal Investigator: Steve Springmeyer, Biodesix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 12, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BDX-CD-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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