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Nodify Lung Testing for Pulmonary Nodules

Study acronym: STRATIFY
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07858552
Lead Sponsor Biodesix, Inc.
Conditions
(from sponsor)		 Indeterminate Pulmonary Nodule
Related terms Lung Neoplasms
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov