Actively Recruiting
Using Liquid Biopsy Testing to Identify, Monitor, Predict Recurrence in Urothelial Carcinoma
Led by Tianjin Medical University Second Hospital · Updated on 2026-03-02
300
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a non-invasive multi-component liquid biopsy test for patients with urothelial carcinoma, including bladder cancer and upper tract urothelial carcinoma. This observational study aims to assess how well this blood and urine-based test can help diagnose the cancer, monitor treatment response, and predict cancer recurrence. The study is sponsored by Tianjin Medical University Second Hospital and focuses on improving auxiliary diagnosis and monitoring using several tumor-derived markers. The liquid biopsy test combines multiple components such as circulating tumor DNA (ctDNA) and cell-free DNA from blood plasma and urine, exosomal RNAs, and selected tumor-associated proteins from urine. Samples are collected at key clinical times: before diagnosis or at baseline, during treatment, and in the post-treatment surveillance period. This allows researchers to track changes in tumor markers throughout the disease course. Participants will provide paired blood and urine samples for this longitudinal assessment. Researchers will measure diagnostic concordance at baseline and assess dynamic changes during treatment and follow-up visits scheduled at intervals such as 4 to 8 weeks during treatment, and then at 3, 6, 12 months, and yearly up to 24 to 36 months or until disease progression or recurrence. The study involves careful monitoring and sample collection over several years to understand the test's utility in clinical practice.
CONDITIONS
Brief Title
Using Liquid Biopsy Testing to Identify, Monitor, Predict Recurrence in Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected or histologically confirmed urothelial carcinoma
You will not qualify if you...
- History of or concurrent active malignancy other than urothelial carcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline (pre-treatment or diagnosis confirmation)
Participants undergo a non-invasive liquid biopsy assay to identify urothelial carcinoma using blood and urine samples at baseline.
1 visit (in-person)
Duration - Up to 24 to 36 months or until progression/recurrence
Participants have serial liquid biopsy assessments during treatment and post-treatment to monitor disease status and predict recurrence.
Visits at baseline, during treatment (e.g., every 4 to 8 weeks), and post-treatment (e.g., at 3, 6, 12 months, and annually thereafter)
Trial Site Locations
Total: 1 location
1
The second hospital of Tianjin Medical University
Tianjin, China, 300000
Actively Recruiting
Research Team
H
Hailong Hu, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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