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Life sciences · Observational Study
ClinicalTrials.gov · October 5, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Observational Study.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07858552). This is a study registration, not published results. Lead sponsor: Biodesix, Inc.. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 1000 participants (ESTIMATED). Conditions: Indeterminate Pulmonary Nodule. Primary outcome measures: Change in Risk Stratification Following Nodify Lung Testing , 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 , Baseline to post-test assessment (following receipt of test results, approximately 1-14 days after blood collection); Clinical Outcomes by Post-Test Risk Category , Up to 24 months. Brief 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. 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.