Nodule Solitary PulmonaryORACLENCT03766958
A Registry to Evaluate the Performance of the BDX-XL2 Test
An observational study of Nodule Solitary Pulmonary and NSCLC, run by Biodesix, Inc. at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Nodule Solitary Pulmonary, NSCLC
- How many people
- 842 participants
- Where
- 15 sitesUnited States
- Study dates
- 16 Oct 2018to 23 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be identified from the patient populations of participating pulmonary medicine practices.
Who may be able to join
- Patient has provided informed consent to participate in the registry and agrees to comply with all protocol requirements.
- 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.
- The first CT scan identifying the lung nodule of concern was performed within 60 days of patient enrollment in the registry.
Who cannot join
- 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.
- High risk per physician assessment (i.e. > 65% by physician pCA)
- Current diagnosis of any active cancer.
- Prior diagnosis of lung cancer.
- Prior diagnosis of any cancer within 5 years of lung nodule detection, except for non-melanomatous skin cancer.
- Concurrent participation in any unrelated clinical trial that may impact or alter the management of the patient's nodule of concern.
- Any illness or factor that will prevent compliance with follow-up as recommended.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Peacehealth
Bellingham, Washington, 98225
University of Cincinnati
Cincinnati, Ohio, 45267
Clinical Research Associates of Central PA/Penn Highlands Hospital
DuBois, Pennsylvania, 15801
Parkview Research Center
Fort Wayne, Indiana, 46845
East Carolina University
Greenville, North Carolina, 27858
University of Nevada, Las Vegas
Las Vegas, Nevada, 89154
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Amicis Research Center
Northridge, California, 91324
Pinehurst Medical Clinic
Pinehurst, North Carolina, 28374
The Oregon Clinic
Portland, Oregon, 97220
Pueblo Pulmonary Associates
Pueblo, Colorado, 81003
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Stamford Health
Stamford, Connecticut, 06904
Banner Health
Sun City, Arizona, 85351
Southeastern Research Center
Winston-Salem, North Carolina, 27103
About this study
Official title: 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.
- Conditions
- Nodule Solitary Pulmonary, NSCLC
- Medical subject headings
- Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Statistically significant change in the proportion of benign lung nodules managed by Nodify Lung experiencing invasive procedures.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start16 Oct 2018
- Primary completion12 May 2022
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nodule Solitary PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 842 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biodesix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Springmeyer, Principal investigator, Biodesix, Inc.Michael Pritchett, DO, Principal investigator, Pinehurst Medical Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766958
- Sponsor's protocol ID
- BDX-CD-002
- Acronym
- ORACLE
- Status last verified
- May 2024
- First submitted
- 5 Dec 2018
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37432960
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Registry Study to Evaluate the Performance of the BDX-XL2 Test
- ClinicalTrials.gov ID
- NCT03766958
- Acronym / sponsor ID
- ORACLE / BDX-CD-002
- Conditions
- Nodule Solitary Pulmonary, NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 842 participants (actual)
- Lead sponsor
- Biodesix, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be identified from the patient populations of participating pulmonary medicine practices.
Key inclusion criteria (6 listed)
- Patient has provided informed consent to participate in the registry and agrees to comply with all protocol requirements.
- Patient meets the criteria for the intended use population of Nodify Lung testing:
- The first CT scan identifying the lung nodule of concern was performed within 60 days of patient enrollment in the registry.
Key exclusion criteria (7 listed)
- 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.
- High risk per physician assessment (i.e. > 65% by physician pCA)
- Current diagnosis of any active cancer.
- Prior diagnosis of lung cancer.
- Prior diagnosis of any cancer within 5 years of lung nodule detection, except for non-melanomatous skin cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Statistically significant change in the proportion of benign lung nodules managed by Nodify Lung experiencing invasive procedures.
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Derived from this study: PubMed 37432960Pritchett 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Springmeyer principal investigator
Biodesix, Inc.
Michael Pritchett, DO principal investigator
Pinehurst Medical Clinic
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nodule Solitary Pulmonary and NSCLC, run by Biodesix, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistically significant change in the proportion of benign lung nodules managed by Nodify Lung experiencing invasive procedures. (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03766958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.