Using Liquid Biopsy Testing to Identify, Monitor, Predict Recurrence in Urothelial Carcinoma

Condition(s) studied

Investigational drug(s) / intervention(s)

Multi-Component Liquid Biopsy for Urothelial Carcinoma: This intervention is a non-invasive, multi-component liquid biopsy assay specifically designed for patients with urothelial carcinoma (including bladder cancer and upper tract urothelial carcinoma). It integrates multiple tumor-derived analytes from paired blood and urine samples: circulating cell-free DNA (cfDNA)/circulating tumor DNA (ctDNA) from peripheral blood plasma, urinary tumor DNA (utDNA)/cell-free DNA from urine, exosomal RNAs (e.g., miRNAs, lncRNAs) and proteins from urine-derived exosomes, and selected tumor-associated proteins. Serial sampling is performed at key clinical time points to enable longitudinal assessment: 1. Pre-diagnosis or baseline 2. During treatment 3. Post-treatment surveillance

Study summary

Application of Multi-Component Liquid Biopsy (ctDNA, utDNA, Exosomes, and Protein Biomarkers in Blood and Urine) for Auxiliary Diagnosis, Therapeutic Response Evaluation, and Recurrence Monitoring in Urothelial Carcinoma

Eligibility

Primary outcome measure(s)

• Diagnostic Concordance — At baseline (pre-treatment/diagnosis confirmation) or within the diagnostic window.
  The proportion of patients in whom the molecular alterations (e.g., somatic mutations in key genes such as FGFR3, TP53, TERT promoter, PLEKHS1; methylation signatures; or multi-omic features) detected in multi-component liquid biopsy (blood ctDNA/cfDNA + urine utDNA/exosomal components) match those identified in the reference tissue biopsy or surgical specimen (gold standard).

Trial sites (1)

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