Indeterminate Pulmonary NoduleSTRATIFYNCT07858552
Nodify Lung Testing for Pulmonary Nodules
An observational study of Indeterminate Pulmonary Nodule, run by Biodesix, Inc..
Trial summary
The STRATIFY Study is an observational study for adults age 40 or older who have a lung nodule that is not clearly benign or cancerous. The study will enroll up to 1,000 participants at about 10-12 U.S. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Indeterminate Pulmonary Nodule
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Nov 2030
- How long will I take part?
- 24 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 40 years and older with indeterminate pulmonary nodules undergoing routine clinical evaluation and blood-based risk assessment at participating U.S. sites.
Who may be able to join
- The participant is willing and able to provide informed consent and agrees to comply with all protocol requirements.
- The participant is an adult, 40 years of age or older at the time of enrollment.
- The participant has at least one pulmonary nodule measuring 4mm to 30mm in maximum diameter based on CT imaging.
- The pulmonary nodule of concern is solid or part solid.
- The pulmonary nodule of concern was identified either incidentally or as part of a lung cancer screening program.
- The participant has an estimated pre-test probability of malignancy (pCA) ≤65%, as determined by the treating physician using an established risk prediction model (e.g., Mayo Clinic Model)
Who cannot join
- History of lung cancer any time prior to enrollment or an active malignancy requiring treatment, active surveillance within 5 years prior to identification of the nodule of concern.
- Pulmonary nodule of concern with a pre-test probability of malignancy (pCA) >65%, as determined by the treating physician using an established risk prediction model (e.g., Mayo Clinic Model)
- The pulmonary nodule of concern is a ground glass opacity (GGO)
- Prior definitive diagnosis through histopathological confirmation or empiric radiation treatment of the nodule of concern.
- Prior definitive diagnosis or empiric radiation treatment of the nodule of concern before enrollment
- Prior use of Nodify CDT test, Nodify XL2 test, or another molecular classifier for evaluation of the index pulmonary nodule before enrollment.
- Participation in another interventional clinical study or other lung nodule management related tests that, in the opinion of the investigator, could influence management or outcomes of the index pulmonary nodule.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Noor Director, Clinical Operations contact
About this study
Official title: A Multicenter Prospective Observational Registry Evaluating Risk Stratification, Clinical Management Decisions, and Clinical Outcomes Following the Nodify Lung® Sequential Testing Strategy in Patients With Indeterminate Pulmonary Nodules
The STRATIFY Study is an observational study for adults age 40 or older who have a lung nodule that is not clearly benign or cancerous. The study will enroll up to 1,000 participants at about 10-12 U.S. sites and will examine how the Nodify Lung blood tests affect doctors' estimates of cancer risk, care recommendations, and patient outcomes. Participants will provide informed consent and have a routine blood draw. The study does not assign treatment or require additional diagnostic procedures, and all medical decisions remain with the treating clinician. The main additional risks are those associated with a routine blood draw and a small risk to privacy. Participation is voluntary, may not provide a direct medical benefit, and may help improve how lung nodules are evaluated in the future.
Read the detailed description
Pulmonary nodules are commonly identified during chest imaging performed for lung cancer screening or other medical evaluations. Determining whether a nodule is benign or malignant can be challenging, particularly for nodules with an intermediate probability of malignancy. Uncertainty in risk assessment may lead to additional imaging, invasive diagnostic procedures, prolonged surveillance, and variation in clinical management decisions.
The STRATIFY Study is a prospective, multicenter, observational registry designed to evaluate the use of the commercially available Nodify Lung® blood-testing strategy in routine clinical practice among adults with indeterminate pulmonary nodules. The study will assess how blood test results influence physician assessment of lung cancer risk, subsequent management recommendations, and clinical outcomes during routine care.
Participants will be enrolled after a treating physician has independently decided to use the Nodify Lung testing strategy as part of standard clinical evaluation. The study is observational in nature and does not require protocol-directed treatment, diagnostic procedures, imaging schedules, or follow-up visits beyond routine medical care. All decisions regarding surveillance, additional testing, biopsy, surgery, or treatment remain under the direction of the treating clinician.
Data collected during the study will include baseline clinical characteristics, physician-estimated risk assessments, blood test results, management recommendations, subsequent diagnostic procedures, and clinical outcomes. Participants may be followed for up to 24 months to document diagnostic evaluations and final nodule outcomes. Outcomes of interest include changes in physician risk assessment, changes in intended management following test results, utilization of diagnostic procedures, and determination of whether the nodule is ultimately classified as benign or malignant.
The information generated from this study is intended to improve understanding of how blood-based risk stratification tools are incorporated into real-world pulmonary nodule management and how these tools may support clinical decision-making for patients undergoing evaluation of indeterminate pulmonary nodules.
- Conditions
- Indeterminate Pulmonary Nodule
- Keywords
- Pulmonary nodule, Indeterminate Lung Nodule, Suspected Lung Cancer, Lung Cancer
- Medical subject headings
- Lung Neoplasms
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 |
|---|---|---|
| Adults With Indeterminate Pulmonary Nodules Undergoing Nodify Lung Testing | Adults aged 40 years or older with one or more indeterminate pulmonary nodules (4-30 mm) undergoing routine clinical evaluation and for whom the treating physician has elected to use the commercially available Nodify Lung blood-testing strategy as part of standard clinical care. Participants are enrolled in a prospective observational registry and followed through routine medical care to assess risk stratification, physician management decisions, and clinical outcomes. The study does not assign diagnostic procedures, treatments, or management strategies; all clinical decisions remain at the discretion of the treating physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Risk Stratification Following Nodify Lung Testing
Distribution of participants across post-test probability of malignancy risk categories and change from pre-test risk assessment following receipt of Nodify Lung test results.
Measured: Baseline to post-test assessment (following receipt of test results, approximately 1-14 days after blood collection)
Change in Physician Management Recommendations Following Nodify Lung Testing
Proportion of participants with a change in intended clinical management after receipt of Nodify Lung test results compared with the pre-test management plan. Management options may include CT surveillance, PET/CT imaging, biopsy, surgical consultation, surgical intervention, or other diagnostic approaches.
Measured: Baseline to post-test assessment (following receipt of test results, approximately 1-14 days after blood collection)
Clinical Outcomes by Post-Test Risk Category
Proportion of participants with malignant and benign final nodule outcomes within each post-test risk category following routine clinical follow-up.
Measured: Up to 24 months
Secondary outcomes (2)
Performance Evaluation of BDSX-032
Evaluate the performance of BDSX-032 in participants with indeterminate pulmonary nodules using final clinical outcome data collected during study follow-up.
Measured: Up to 24 months
Performance Evaluation of BDSX-032 in Combination With the Nodify Lung Testing Strategy
Evaluate the performance of BDSX-032 when assessed in combination with the Nodify Lung testing strategy using final clinical outcome data collected during study follow-up.
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 posted5 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indeterminate Pulmonary NoduleStudies 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
- 1,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Biodesix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858552
- Sponsor's protocol ID
- BDSX-CD-013
- Acronym
- STRATIFY
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Observational Registry Evaluating Risk Stratification, Clinical Management Decisions, and Clinical Outcomes Following the Nodify Lung® Sequential Testing Strategy in Patients With Indeterminate Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT07858552
- Acronym / sponsor ID
- STRATIFY / BDSX-CD-013
- Conditions
- Indeterminate Pulmonary Nodule
- Keywords
- Pulmonary nodule, Indeterminate Lung Nodule, Suspected Lung Cancer, Lung Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Biodesix, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 5 Oct 2026 (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 STRATIFY Study is an observational study for adults age 40 or older who have a lung nodule that is not clearly benign or cancerous. The study will enroll up to 1,000 participants at about 10-12 U.S. sites and will examine how the Nodify Lung blood tests affect doctors' estimates of cancer risk, care recommendations, and patient outcomes. Participants will provide informed consent and have a routine blood draw. The study does not assign treatment or require additional diagnostic procedures, and all medical decisions remain with the treating clinician. The main additional risks are those associated with a routine blood draw and a small risk to privacy. Participation is voluntary, may not provide a direct medical benefit, and may help improve how lung nodules are evaluated in the future.
Detailed description
Pulmonary nodules are commonly identified during chest imaging performed for lung cancer screening or other medical evaluations. Determining whether a nodule is benign or malignant can be challenging, particularly for nodules with an intermediate probability of malignancy. Uncertainty in risk assessment may lead to additional imaging, invasive diagnostic procedures, prolonged surveillance, and variation in clinical management decisions.
The STRATIFY Study is a prospective, multicenter, observational registry designed to evaluate the use of the commercially available Nodify Lung® blood-testing strategy in routine clinical practice among adults with indeterminate pulmonary nodules. The study will assess how blood test results influence physician assessment of lung cancer risk, subsequent management recommendations, and clinical outcomes during routine care.
Participants will be enrolled after a treating physician has independently decided to use the Nodify Lung testing strategy as part of standard clinical evaluation. The study is observational in nature and does not require protocol-directed treatment, diagnostic procedures, imaging schedules, or follow-up visits beyond routine medical care. All decisions regarding surveillance, additional testing, biopsy, surgery, or treatment remain under the direction of the treating clinician.
Data collected during the study will include baseline clinical characteristics, physician-estimated risk assessments, blood test results, management recommendations, subsequent diagnostic procedures, and clinical outcomes. Participants may be followed for up to 24 months to document diagnostic evaluations and final nodule outcomes. Outcomes of interest include changes in physician risk assessment, changes in intended management following test results, utilization of diagnostic procedures, and determination of whether the nodule is ultimately classified as benign or malignant.
The information generated from this study is intended to improve understanding of how blood-based risk stratification tools are incorporated into real-world pulmonary nodule management and how these tools may support clinical decision-making for patients undergoing evaluation of indeterminate pulmonary nodules.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults With Indeterminate Pulmonary Nodules Undergoing Nodify Lung Testing | – | –Adults aged 40 years or older with one or more indeterminate pulmonary nodules (4-30 mm) undergoing routine clinical evaluation and for whom the treating physician has elected to use the commercially available Nodify Lung blood-testing strategy as part of standard clinical care. Participants are enrolled in a prospective observational registry and followed through routine medical care to assess risk stratification, physician management decisions, and clinical outcomes. The study does not assign diagnostic procedures, treatments, or management strategies; all clinical decisions remain at the discretion of the treating physician. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 40 years and older with indeterminate pulmonary nodules undergoing routine clinical evaluation and blood-based risk assessment at participating U.S. sites.
Key inclusion criteria (6 listed)
- The participant is willing and able to provide informed consent and agrees to comply with all protocol requirements.
- The participant is an adult, 40 years of age or older at the time of enrollment.
- The participant has at least one pulmonary nodule measuring 4mm to 30mm in maximum diameter based on CT imaging.
- The pulmonary nodule of concern is solid or part solid.
- The pulmonary nodule of concern was identified either incidentally or as part of a lung cancer screening program.
Key exclusion criteria (7 listed)
- History of lung cancer any time prior to enrollment or an active malignancy requiring treatment, active surveillance within 5 years prior to identification of the nodule of concern.
- Pulmonary nodule of concern with a pre-test probability of malignancy (pCA) >65%, as determined by the treating physician using an established risk prediction model (e.g., Mayo Clinic Model)
- The pulmonary nodule of concern is a ground glass opacity (GGO)
- Prior definitive diagnosis through histopathological confirmation or empiric radiation treatment of the nodule of concern.
- Prior definitive diagnosis or empiric radiation treatment of the nodule of concern before 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
Change in Risk Stratification Following Nodify Lung Testing
Time frame: Baseline to post-test assessment (following receipt of test results, approximately 1-14 days after blood collection)
Distribution of participants across post-test probability of malignancy risk categories and change from pre-test risk assessment following receipt of Nodify Lung test results.
Change in Physician Management Recommendations Following Nodify Lung Testing
Time frame: Baseline to post-test assessment (following receipt of test results, approximately 1-14 days after blood collection)
Proportion of participants with a change in intended clinical management after receipt of Nodify Lung test results compared with the pre-test management plan. Management options may include CT surveillance, PET/CT imaging, biopsy, surgical consultation, surgical intervention, or other diagnostic approaches.
Clinical Outcomes by Post-Test Risk Category
Time frame: Up to 24 months
Proportion of participants with malignant and benign final nodule outcomes within each post-test risk category following routine clinical follow-up.
2 secondary outcomes
Performance Evaluation of BDSX-032
Time frame: Up to 24 months
Performance Evaluation of BDSX-032 in Combination With the Nodify Lung Testing Strategy
Time frame: Up to 24 months
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 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Noor Director, Clinical Operations contact
Questions about this trial
What is this clinical trial studying?
An observational study of Indeterminate Pulmonary Nodule, run by Biodesix, Inc..
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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Niki VP, Clinical Research ((720) 495-1583, niki.givens@biodesix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Risk Stratification Following Nodify Lung Testing (time frame: Baseline to post-test assessment (following receipt of test results, approximately 1-14 days after blood collection)). The study lists 3 primary outcomes in all. 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 5 Oct 2026.