NCT07858552Not yet recruiting
Nodify Lung Testing for Pulmonary Nodules
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
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 29 Sept 2026
- Start date
- Nov 2026
- Primary completion date
- Nov 2030
- Lead sponsor
- Biodesix, Inc.
- Diseases
- Lung cancer
- NCT number
- NCT07858552
What you commit to
- Study type: Observational
- Planned participants: 1000
- From Nov 2026 to the primary completion date, Nov 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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)
Other
- The pulmonary nodule of concern is a ground glass opacity (GGO)
- 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.
Who the study is looking for
- 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)
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.