Actively Recruiting
Noninvasive Urine Testing for Urothelial Carcinoma: A Two-Stage Prospective Single-Center Observational Study
Led by Henan Provincial People's Hospital · Updated on 2026-05-29
800
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating noninvasive urine tests to detect urothelial carcinoma (UC), a type of cancer affecting the urinary tract. This prospective, single-center observational study involves adults who have visible or microscopic blood in their urine and imaging evidence of a lesion in the renal pelvis, ureter, or bladder. The study aims to compare the accuracy of different urine tests using tissue biopsy results as the reference standard. The study has two stages. In Stage 1 (completed), participants underwent four types of urine tests: cytology, fluorescence in situ hybridization (FISH), DNA methylation, and a 17-gene mutation panel. Stage 2 (ongoing) focuses only on urine DNA methylation due to funding and cost considerations. Participants are divided into two groups based on biopsy results: those with UC and those without. The research assesses how well each urine test detects UC and compares their diagnostic performance. Participants provide urine samples and undergo scheduled tissue biopsies or surgery for diagnosis. Researchers analyze urine and histopathology results to measure test accuracy, including sensitivity and specificity. The study tracks outcomes within four weeks of urine collection and biopsy. Data collected will help determine if urine DNA methylation is a reliable, less invasive way to detect UC. The total study duration runs through December 2030.
CONDITIONS
Brief Title
Noninvasive Urine Testing for Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Presence of gross or microscopic hematuria
- Imaging evidence of a lesion in the renal pelvis, ureter, or bladder
- Scheduled for surgery for tissue histopathological diagnosis
- Able to provide written informed consent
You will not qualify if you...
- Inadequate urine sample (poor quality or insufficient volume)
- Lack of final histopathological diagnosis
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.
Duration - Up to 4 weeks
Participants provide urine samples and undergo imaging and surgery for tissue histopathological diagnosis to evaluate urothelial carcinoma.
1 to 2 visits including urine collection and surgery
Trial Site Locations
Total: 1 location
1
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
Research Team
K
Kunpeng Shu
J
Junya Yan, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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