Urothelial Carcinoma (UC)NCT07614594
Non-invasive Urinary Genomics-Based Risk Assessment for Early Urothelial Carcinoma Diagnosis
An observational study of Urothelial Carcinoma (UC) and Upper Tract Urothelial Carcinoma, run by Henan Provincial People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma (UC), Upper Tract Urothelial Carcinoma, UTUC
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2019to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Inadequate urine sample (poor quality or insufficient volume).
- Lack of final histopathological diagnosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Kunpeng Shu, +8615515696659, kunpengshu@163.com
About this study
Official title: Non-invasive Urinary Genomics-Based Risk Assessment for Early Diagnosis of Urothelial Carcinoma
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):
Read more
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.
- 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
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: At the time of urine collection and subsequent histopathological diagnosis (within 4 weeks of urine collection).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start8 Oct 2019
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhifeng Wang, PhD, Principal investigator, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614594
- Sponsor's protocol ID
- 2019-IRB-73
- Status last verified
- Jun 2026
- First submitted
- 11 May 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Urinary Genomics-Based Risk Assessment for Early Diagnosis of Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT07614594
- Acronym / sponsor ID
- 2019-IRB-73
- Keywords
- urothelial carcinoma, upper tract urothelial carcinoma, DNA methylation, 17 genes mutation, diagnosis, bladder cancer, diagnostic efficacy, urine sample
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Inadequate urine sample (poor quality or insufficient volume).
- Lack of final histopathological diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhifeng Wang, PhD principal investigator
Henan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma (UC) and Upper Tract Urothelial Carcinoma, run by Henan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kunpeng Shu (+8615515696659, kunpengshu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.