TOBY ATLAS is a multi-center master protocol that supports the development and validation of urine-based tests for screening, diagnosis, and monitoring of multiple diseases. The study uses prospectively collected, residual, banked, and purchased urine samples, where permitted.
Researchers will analyze urine for volatile organic compounds using gas chromatography-mass spectrometry and develop models using samples with known disease status. Each model will be locked before it is evaluated using a separate set of blinded samples.
Disease status and available standard-of-care test results will be obtained from medical records. Researchers may also review records over time to identify later diagnoses or outcomes. Sites and diseases may be added as the study progresses.
