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Noninvasive Urine Testing for Urothelial Carcinoma

NCT07614594 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2026-05-29

No results posted yet for this study

Summary

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.

Conditions

  • Urothelial Carcinoma (UC)
  • Upper Tract Urothelial Carcinoma
  • UTUC
  • Bladder Cancer (BC)

Sponsors & Collaborators

  • Henan Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Zhifeng Wang, PhD · Henan Provincial People's Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-08
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07614594 on ClinicalTrials.gov