Bladder (Urothelial, Transitional Cell) Cancer, Liquid Biopsy, Urothelial Carcinoma (UC)
Conditions
Brief 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
Interventions
DIAGNOSTIC_TESTMulti-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
Sponsors
Tianjin Medical University Second Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Suspected or histologically confirmed urothelial carcinoma
Exclusion criteria
* History of or concurrent active malignancy other than urothelial carcinoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic concordance during treatment/follow-up | Serial assessments at baseline, during treatment (e.g., after each cycle or at predefined intervals such as 4-8 weeks), post-treatment (e.g., 3, 6, 12 months, and annually thereafter), up to 24-36 months or until progression/recurrence | The degree of agreement between longitudinal changes in multi-component liquid biopsy markers (primarily variant allele frequency \[VAF\] of key somatic mutations in ctDNA from blood and utDNA from urine, as well as exosomal RNA/protein levels where applicable) and clinical/radiological/pathological response endpoints |
Countries
China
Contacts
CONTACTHailong Hu, MD
Outcome results
None listed