Nodule Solitary PulmonaryALTITUDENCT04171492
Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules
An observational study of Nodule Solitary Pulmonary and Non-small Cell Carcinoma, run by Biodesix, Inc. at 25 sites in 2 countries.
Trial summary
This study evaluates the how addition of the Nodify XL2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Nodule Solitary Pulmonary, Non-small Cell Carcinoma
- How many people
- 2,000 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 18 Dec 2020to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Subjects with newly identified, solid lung nodule determined to be low-moderate risk of cancer.
Who may be able to join
- Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements
- Subject is > 40 years of age at the time of the discovery of the lung nodule of concern
- Subject's lung nodule of concern meets the following:
- Was incidentally identified or detected during lung cancer screening
- Is a solid nodule
- Has maximal dimension of > 8mm and < 30mm
- The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment
- The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less
Who cannot join
- Nodule work-up at the time of subject enrollment indicating any prior attempted or completed diagnostic biopsy procedure or blood-based testing for the lung nodule of concern
- Nodule of concern is part-solid or Ground Glass Opacity (GGO)
- Prior diagnosis of lung cancer
- Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer
- Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment
- Concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern
- Any illness or factor that will inhibit compliance with study participation
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States23 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
The Johns Hopkins University
Baltimore, Maryland, 21205
Massachusetts General Hospital
Boston, Connecticut, 02114
Beth Israel Deaconess
Boston, Connecticut, 02215
The University of North Carolina
Chapel Hill, North Carolina, 27599
Ralph H Johnson VA Medical Center
Charleston, South Carolina, 29401
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University
Coulmbus, Ohio, 43210
University of Texas Southwestern
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27705
University of Texas Medical Branch
Galveston, Texas, 77555
Prisma Health
Greenville, South Carolina, 29605
Indiana University
Indianapolis, Indiana, 46202
Mount Sinai Health System
New York, New York, 10029
Northwell Health
New York, New York, 11042
The Oregon Clinic
Portland, Oregon, 97220
Virginia Commonwealth University
Richmond, Virginia, 23219
Mayo Clinic
Rochester, Minnesota, 55905
The Washington University
St Louis, Missouri, 63110
MedStar
Washington D.C., District of Columbia, 20010
Southeastern Research Center
Winston-Salem, North Carolina, 27103
Canada2 sites
University of Calgary
Calgary, Alberta, T2W 1S7
McGill University Health Centre
Montreal, Quebec, H3H 2R9
About this study
Official title: A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules
This study evaluates the how addition of the Nodify XL2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer.
Read the detailed description
A multicenter, randomized controlled study with a blinded control arm. Open label arm is observational for lung nodule management. The clinical trial will evaluate the clinical utility of the Nodify XL2 integrated classifier when used in the clinical management of newly identified solid lung nodules assessed as < 50% risk of cancer by Mayo risk prediction algorithm.
- 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 |
|---|---|---|
| Open Label | Nodify XL2 results will be reported to the investigator and available to the subject. | |
| Blinded | Nodify XL2 results will not be available to the investigative site or subject. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Nodule Diagnosis
Malignant diagnosis through histology/pathology or benign diagnosis through histology/pathology, radiologic stability or radiologic confirmation of nodule resolution
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start18 Dec 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biodesix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Springmeyer, Principal investigator, Biodesix, Inc.Gerard Silvestri, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171492
- Sponsor's protocol ID
- BDX-CD-003
- Acronym
- ALTITUDE
- Status last verified
- Sep 2025
- First submitted
- 19 Nov 2019
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules
- ClinicalTrials.gov ID
- NCT04171492
- Acronym / sponsor ID
- ALTITUDE / BDX-CD-003
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Biodesix, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Nov 2019 (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.
This study evaluates the how addition of the Nodify XL2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer.
Detailed description
A multicenter, randomized controlled study with a blinded control arm. Open label arm is observational for lung nodule management. The clinical trial will evaluate the clinical utility of the Nodify XL2 integrated classifier when used in the clinical management of newly identified solid lung nodules assessed as < 50% risk of cancer by Mayo risk prediction algorithm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Label | – | –Nodify XL2 results will be reported to the investigator and available to the subject. |
| Blinded | – | –Nodify XL2 results will not be available to the investigative site or subject. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects with newly identified, solid lung nodule determined to be low-moderate risk of cancer.
Key inclusion criteria (8 listed)
- Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements
- Subject is > 40 years of age at the time of the discovery of the lung nodule of concern
- Subject's lung nodule of concern meets the following:
- The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment
- The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less
Key exclusion criteria (7 listed)
- Nodule work-up at the time of subject enrollment indicating any prior attempted or completed diagnostic biopsy procedure or blood-based testing for the lung nodule of concern
- Nodule of concern is part-solid or Ground Glass Opacity (GGO)
- Prior diagnosis of lung cancer
- Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer
- Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment
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
Lung Nodule Diagnosis
Time frame: Up to 24 months
Malignant diagnosis through histology/pathology or benign diagnosis through histology/pathology, radiologic stability or radiologic confirmation of nodule resolution
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
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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.
Steven Springmeyer principal investigator
Biodesix, Inc.
Gerard Silvestri, MD principal investigator
Medical University of South Carolina
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nodule Solitary Pulmonary and Non-small Cell Carcinoma, run by Biodesix, Inc. at 25 sites in 2 countries.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Lung Nodule Diagnosis (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2025.