Noninvasive Urine Testing for Urothelial Carcinoma

NCT07614594 | Recruiting

• 1 other identifier: 2019-IRB-73
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

urothelial carcinoma; upper tract urothelial carcinoma; DNA methylation; 17 genes mutation; diagnosis; bladder cancer; diagnostic efficacy; urine sample; cytology; fluorescence in situ hybridization; non-invasive detection

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of four urine-based tests in the Stage 1 cohort

  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 Outcomes (2)

• Diagnostic accuracy of urine DNA methylation in the Stage 2 cohort

  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

  At the time of urine collection and subsequent histopathological diagnosis (within 4 weeks of urine collection).

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients are eligible if they meet all of the following criteria:
• Age ≥ 18 years.
• Presence of gross or microscopic hematuria.
• Imaging (B-ultrasonography, CT, or MRI) showing a renal pelvic, ureteral, or bladder lesion.
• Scheduled for surgery for tissue histopathological diagnosis.
• Able to provide written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

First morning urine collected from patients for urine cytology，fluorescence in situ hybridization (FISH)，DNA methylation，and 17-gene mutation test.

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Urinary Bladder Neoplasms; Disease

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhifeng Wang, PhD

  Henan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kunpeng Shu

CONTACT

+8615515696659; kunpengshu@163.com

Junya Yan, PhD

CONTACT

+8618811510659; yjunya1471@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 29, 2026
• Study Start: October 8, 2019
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)