Condition: Urothelial Carcinoma (UC) · Upper Tract Urothelial Carcinoma · UTUC · Sponsor: Henan Provincial People's Hospital
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 uri…
This description comes directly from the study's public registry record.
Kunpeng Shu · +8615515696659 · kunpengshu@163.com
Junya Yan, PhD · +8618811510659 · yjunya1471@126.com
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| Henan Provincial People's Hospital | Zhengzhou, Henan, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07614594