Using Liquid Biopsy Testing to Identify, Monitor, Predict Recurrence in Urothelial Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTianjin Medical University Second Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Suspected or histologically confirmed urothelial carcinoma
Disqualifiers
History of or concurrent active malignancy other than urothelial carcinoma
Trial population
This observational cohort study enrolls adult patients (≥18 years) with suspected or histologically confirmed urothelial carcinoma (UC), including non-muscle-invasive bladder cancer (NMIBC), muscle-invasive bladder cancer (MIBC), metastatic urothelial carcinoma, and upper tract urothelial carcinoma (UTUC) of the renal pelvis or ureter. Participants are recruited from urology/oncology clinics at participating centers. The study population consists: Patients with clinical suspicion of UC and patients with pathologically confirmed UC at any stage.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Multi-Component Liquid Biopsy for Urothelial Carcinoma
Diagnostic testThis 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
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Study group1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic Concordance
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).
Time frame
At baseline (pre-treatment/diagnosis confirmation) or within the diagnostic window.Secondary outcomes
1
Dynamic concordance during treatment/follow-up
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
Time frame
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/recurrenceSponsors and contacts
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Source ClinicalTrials.gov