Non-invasive Urinary Genomics-Based Risk Assessment for Early Urothelial Carcinoma Diagnosis
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a two-stage, prospective, single-center observational diagnostic accuracy study evaluating noninvasive urine testing for the detection of urothelial carcinoma (UC). The study enrolls adult patients presenting with gross or microscopic hematuria and imaging evidence of a space-occupying lesion in the renal pelvis, ureter, or bladder, who are scheduled for diagnostic cystoscopy and/or surgical tissue sampling. Histopathological examination serves as the reference standard. Stage 1 (Completed, 8th October 2019 - 31st December 2023): A total of 113 participants have been enrolled. Owing to sufficient research funding, all participants in this stage underwent four urine-based tests: cytology, fluorescence in situ hybridization (FISH), DNA methylation, and a 17-gene mutation panel. Stage 2 (Ongoing, from 1st January 2024): The testing protocol was refined to focus on urine DNA methylation alone, owing to limited research funding and the lower cost of DNA methylation compared with the 17-gene mutation panel. As of registration (May 2026), approximately 330 participants have been enrolled. All enrolled participants are categorized into two groups based on histopathology: a UC group (including upper tract urothelial carcinoma \[UTUC\] and bladder cancer \[BC\]) and a non-UC control group. The primary outcome is the diagnostic accuracy (area under the receiver operating characteristic curve \[AUC\] with 95% confidence interval, sensitivity, and specificity) of the four urine-based tests in the Stage 1 cohort. The key secondary outcome is the diagnostic accuracy of urine DNA methylation in the Stage 2 cohort. Other secondary outcomes include paired comparisons of AUCs among the four tests in the Stage 1 cohort. Exploratory analyses will include the diagnostic performance of urine cytology in a subset of Stage 2 participants with UTUC, as well as subgroup analyses by tumor site (UTUC vs. BC). Because this study is purely observational and non-interventional, prospective registration was not a regulatory or institutional requirement when enrollment began in 2019. This record is being submitted prior to any data analysis to ensure consistency with current research transparency standards.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Osoby powyżej 18 roku życia.
- •Obecność krwi w moczu (widoczna lub niewidoczna gołym okiem).
- •Badania obrazowe (np. USG, tomografia, rezonans) wykazały zmianę w miedniczce nerkowej, moczowodzie lub pęcherzu.
- •Zaplanowana operacja w celu pobrania wycinka do badania histopatologicznego.
- •Zdolność do wyrażenia pisemnej zgody na udział w badaniu.
✗ Disqualifies
- •Zbyt mała ilość lub niska jakość próbki moczu.
- •Brak ostatecznego rozpoznania histopatologicznego po operacji.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 2, 2026
- Sex
- No restrictions
Locations (1)
Henan Provincial People's Hospital
Zhengzhou, China
Trial contact
Kunpeng Shu
Junya Yan, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.
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