Validation of a Blood Test Detecting Tumor DNA to Monitor Muscle-Invasive Bladder and Upper Tract Urothelial Cancer Observational Study Comparing Tumor and Blood DNA Mutations and Treatment Response

What this Trial Is About

Researchers are evaluating a blood test based on circulating tumor DNA ctDNA in patients with muscle-invasive bladder cancer or upper tract urothelial cancer. The study aims to compare ctDNA detected in blood with tumor-specific mutations identified from tumor tissue analysis. It also explores whether ctDNA results after treatment relate to cancer recurrence or remission over two years, and if changes in ctDNA during treatment correspond to pathological response. The study analyzes tumor DNA from tissue samples collected during routine diagnostic or surgical procedures using next-generation sequencing to identify mutations. Blood samples taken as part of regular clinical care are then tested for these mutations using digital droplet PCR and potentially additional sequencing. No extra blood draws or treatments are assigned by the study, and physicians remain unaware of ctDNA results during the trial. Participants receive standard care as usual. Researchers collect clinical, pathological, treatment, molecular, and follow-up data to assess the ctDNA tests performance and its association with treatment response and disease outcomes. The study includes up to two years of follow-up and aims to validate the ctDNA test for future clinical use in monitoring urothelial cancer.

Validation of a Circulating Tumor DNA Blood Test in Muscle-Invasive Bladder and Upper Tract Urothelial Cancer