Validating UroAmp Collecting Urine and Tumor Samples to Detect and Monitor Bladder Cancer

What this Trial Is About

This research aims to collect urine and tumor samples along with clinical data from patients being evaluated, treated, or monitored for urothelial carcinoma, including bladder cancer. It is a prospective, multicenter observational study designed to validate a new testing platform called UroAmp for detecting and surveilling bladder cancer and related conditions. Participants provide a urine sample at enrollment using a proprietary urine collection system. They are then followed for up to five years, during which urine samples, tissue samples when applicable, and clinical information are collected during their routine care visits. The study includes two groups patients with bladder or upper tract urothelial carcinoma and hematuria controls without cancer history. Participants will be involved in regular clinical visits as part of their standard care, during which samples and data are collected. Researchers will measure outcomes such as recurrence-free survival and diagnostic accuracy for hematuria evaluation over up to five years. The study also compares UroAmp to other urine biomarkers and assesses early detection of cancer recurrence, ensuring ongoing monitoring and data collection throughout the follow-up period.

Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer