Using Liquid Biopsy Testing to Identify, Monitor, Predict Recurrence in Urothelial Carcinoma
1 other identifier
observational
300
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedFirst Posted
Study publicly available on registry
March 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
March 2, 2026
January 1, 2026
10 months
January 20, 2026
February 27, 2026
Conditions
Outcome Measures
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).
At baseline (pre-treatment/diagnosis confirmation) or within the diagnostic window.
Secondary Outcomes (1)
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
Study Arms (1)
Study group
Interventions
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
Eligibility Criteria
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.
You may qualify if:
- Suspected or histologically confirmed urothelial carcinoma
You may not qualify if:
- History of or concurrent active malignancy other than urothelial carcinoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The second hospital of Tianjin Medical University
Tianjin, 300000, China
Biospecimen
Paired peripheral blood plasma and urine samples will be retained from participants with urothelial carcinoma. These include: 1. Blood plasma for circulating cell-free DNA (cfDNA)/circulating tumor DNA (ctDNA) extraction. 2. Urine (voided or catheterized) for urinary tumor DNA (utDNA), cell-free DNA, and potential exosomal components. 3. In some cases, surplus tumor tissue (if available from TURBT or cystectomy) for genomic reference.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2026
First Posted
March 2, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2029
Last Updated
March 2, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared. The primary reason is to protect participant privacy and confidentiality, as the study involves sensitive clinical and molecular data (e.g., ctDNA/utDNA profiles, exosomal components) from patients with urothelial carcinoma. De-identification alone may not fully eliminate re-identification risks in this context, particularly given the rarity of certain genomic alterations and potential linkage to clinical records. Additionally, the informed consent and institutional ethics committee approval did not include provisions for broad secondary use or sharing of raw individual-level data beyond the study team. Results will be disseminated through peer-reviewed publications and aggregate summaries to maintain transparency while prioritizing participant protection.