Noninvasive Urine Testing for Urothelial Carcinoma

May 22, 2026 updated by: Henan Provincial People's Hospital

Noninvasive Urine Testing for Urothelial Carcinoma: A Two-Stage Prospective Single-Center Observational Study

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥18 years) presenting with gross or microscopic hematuria, who present with space-occupying lesions in the renal pelvis, ureter, or bladder by imaging (B-ultrasonography, CT, or MRI) and are scheduled for a diagnostic procedure to obtain tissue histopathological diagnosis.

Description

Inclusion Criteria:

Patients are eligible if they meet all of the following criteria:

  1. Age ≥ 18 years.
  2. Presence of gross or microscopic hematuria.
  3. Imaging (B-ultrasonography, CT, or MRI) showing a renal pelvic, ureteral, or bladder lesion.
  4. Scheduled for surgery for tissue histopathological diagnosis.
  5. Able to provide written informed consent.

Exclusion Criteria

  1. Inadequate urine sample (poor quality or insufficient volume).
  2. Lack of final histopathological diagnosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Urothelial Carcinoma Group
Patients with space-occupying lesions diagnosed with UC by histopathology.
Non-Urothelial Carcinoma Group
Non-Urothelial Carcinoma Group. Description: Patients with space-occupying lesions not diagnosed with UC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of four urine-based tests in the Stage 1 cohort
Time Frame: At the time of urine collection and subsequent histopathological diagnosis (within 4 weeks of urine collection)
Area under the receiver operating characteristic curve (AUC) with 95% confidence interval (CI), sensitivity, and specificity of cytology, fluorescence in situ hybridization (FISH), DNA methylation, and a 17-gene mutation panel for the detection of urothelial carcinoma (UC) in the Stage 1 cohort, using histopathology as the reference standard.
At the time of urine collection and subsequent histopathological diagnosis (within 4 weeks of urine collection)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of urine DNA methylation in the Stage 2 cohort
Time Frame: At the time of urine collection and subsequent histopathological diagnosis (within 4 weeks of urine collection).
AUC with 95% CI, sensitivity, and specificity of urine DNA methylation for the detection of UC in all participants enrolled in Stage 2, using histopathology as the reference standard.
At the time of urine collection and subsequent histopathological diagnosis (within 4 weeks of urine collection).
Paired comparisons of AUCs among the four tests in the Stage 1 cohort
Time Frame: At the time of urine collection and subsequent histopathological diagnosis (within 4 weeks of urine collection).
Paired comparisons of areas under the ROC curves (AUCs) among cytology, FISH, DNA methylation, and the 17-gene mutation panel for detecting UC in the Stage 1 cohort.
At the time of urine collection and subsequent histopathological diagnosis (within 4 weeks of urine collection).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Provincial People's Hospital

Investigators

  • Principal Investigator: Zhifeng Wang, PhD, Henan Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2019

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 22, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-IRB-73

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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