Urothelial CarcinomaUMT-UCNCT06912672
Performance Evaluation of a Urine-based Methylation Assay for Urothelial Carcinoma
An observational study of Urothelial Carcinoma, run by Shanghai Epiprobe Biotechnology Co., Ltd..
Trial summary
Urothelial carcinoma (UC) is the most common malignancy of the urinary system. Hematuria is a significant clinical manifestation of UC, often diagnosed through invasive procedures. Urine DNA methylation testing is a promising non-invasive method for early UC detection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Evaluate the diagnostic performance of EPIPROBE TAGMe DNA Methylation Detection Kit for Urothelial Cancer
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 31 Dec 2026
- How long will I take part?
- 1 Year
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The initial population suspected of having urothelial carcinoma with hematuria
Who may be able to join
- Aged between 18 and 90 years, with gross or microscopic hematuria.
- Able to provide enough urine for testing before surgery.
- Consent to participate in the study and sign the informed consent form.
Who cannot join
- With history of any malignancies (including Urothelial carcinoma).
- Severe urinary tract infection leading to sepsis.
- Patients with indwelling catheters, nephrostomy, or cystostomy.
- Severe liver or kidney failure or other conditions deemed unsuitable for the study.
- Samples with insufficient DNA content or other quality control failures.
- Incomplete clinical or pathological data.
- Patients currently undergoing intravesical or systemic chemotherapy, radiotherapy, immunotherapy, or targeted therapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Performance Evaluation of a Urine-based Methylation Assay for Urothelial Carcinoma in Patients With Hematuria: A Prospective, Multi-center Cohort Study
Urothelial carcinoma (UC) is the most common malignancy of the urinary system. Hematuria is a significant clinical manifestation of UC, often diagnosed through invasive procedures. Urine DNA methylation testing is a promising non-invasive method for early UC detection. To evaluate the sensitivity and specificity of urine DNA methylation testing for detecting UC, using standard clinical and pathological diagnoses as the gold standard.
Read the detailed description
Urothelial carcinoma (UC) is the most common malignancy of the urinary system, and early detection and diagnosis are crucial for patient prognosis. Hematuria is a significant clinical manifestation of UC, but its diagnosis often relies on invasive procedures and imaging, posing a substantial burden on patients. With the advancement of molecular biology techniques, urine DNA methylation testing has emerged as a non-invasive and highly sensitive method for early UC detection. This study aims to evaluate the performance of urine DNA methylation testing in detecting UC in patients with hematuria.
All patients with hematuria will receive standard clinical diagnosis, including examinations, tests, surgeries, and pathological assessments to determine the presence of UC. These clinical diagnoses will serve as the gold standard to evaluate the sensitivity and specificity of urine DNA methylation testing in detecting UC in patients with hematuria.
To ensure accuracy and reliability of the results, select a subset of samples with known test results for external methylation sequencing. Authorized researchers will unblind the samples, and the statistical team will analyze the results, calculating sensitivity, specificity, positive predictive value, and negative predictive value of the urine DNA methylation test.
- Conditions
- Urothelial Carcinoma
- Being tested
- Evaluate the diagnostic performance of EPIPROBE TAGMe DNA Methylation Detection Kit for Urothelial Cancer
- Keywords
- Urothelial Carcinoma, Hematuria, DNA methylation
- Medical subject headings
- Carcinoma, Transitional Cell, Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate the diagnostic performance of EPIPROBE TAGMe DNA Methylation Detection Kit for Urothelial CancerDiagnostic test
The study aims to evaluate the diagnostic performance of the EPIPROBE TAGMe DNA Methylation Detection Kit for the detection of urothelial cancer. This assay utilizes targeted DNA methylation analysis to identify specific epigenetic alterations associated with urothelial malignancies. The performance of the kit will be assessed in terms of sensitivity, specificity, and overall diagnostic accuracy using clinical urine samples from a patient population with hematuria.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of DNA methylation test for urothelial carcinoma
Evaluate the diagnostic performance of EPIPROBE TAGMe DNA Methylation Detection Kit for Urothelial Cancer by calculating the sensitivity, specificity.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies 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
- 1,500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Epiprobe Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Changhai Hospital, RenJi Hospital, Tongji Hospital, First Hospital of China Medical University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912672
- Sponsor's protocol ID
- EPI-UC-2025-01
- Acronym
- UMT-UC
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of a Urine-based Methylation Assay for Urothelial Carcinoma in Patients With Hematuria: A Prospective, Multi-center Cohort Study
- ClinicalTrials.gov ID
- NCT06912672
- Acronym / sponsor ID
- UMT-UC / EPI-UC-2025-01
- Conditions
- Urothelial Carcinoma
- Keywords
- Urothelial Carcinoma, Hematuria, DNA methylation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Shanghai Epiprobe Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Changhai Hospital, RenJi Hospital, Tongji Hospital, First Hospital of China Medical University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Apr 2025 (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.
Urothelial carcinoma (UC) is the most common malignancy of the urinary system. Hematuria is a significant clinical manifestation of UC, often diagnosed through invasive procedures. Urine DNA methylation testing is a promising non-invasive method for early UC detection. To evaluate the sensitivity and specificity of urine DNA methylation testing for detecting UC, using standard clinical and pathological diagnoses as the gold standard.
Detailed description
Urothelial carcinoma (UC) is the most common malignancy of the urinary system, and early detection and diagnosis are crucial for patient prognosis. Hematuria is a significant clinical manifestation of UC, but its diagnosis often relies on invasive procedures and imaging, posing a substantial burden on patients. With the advancement of molecular biology techniques, urine DNA methylation testing has emerged as a non-invasive and highly sensitive method for early UC detection. This study aims to evaluate the performance of urine DNA methylation testing in detecting UC in patients with hematuria.
All patients with hematuria will receive standard clinical diagnosis, including examinations, tests, surgeries, and pathological assessments to determine the presence of UC. These clinical diagnoses will serve as the gold standard to evaluate the sensitivity and specificity of urine DNA methylation testing in detecting UC in patients with hematuria.
To ensure accuracy and reliability of the results, select a subset of samples with known test results for external methylation sequencing. Authorized researchers will unblind the samples, and the statistical team will analyze the results, calculating sensitivity, specificity, positive predictive value, and negative predictive value of the urine DNA methylation test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The initial population suspected of having urothelial carcinoma with hematuria
Key inclusion criteria (3 listed)
- Aged between 18 and 90 years, with gross or microscopic hematuria.
- Able to provide enough urine for testing before surgery.
- Consent to participate in the study and sign the informed consent form.
Key exclusion criteria (7 listed)
- With history of any malignancies (including Urothelial carcinoma).
- Severe urinary tract infection leading to sepsis.
- Patients with indwelling catheters, nephrostomy, or cystostomy.
- Severe liver or kidney failure or other conditions deemed unsuitable for the study.
- Samples with insufficient DNA content or other quality control failures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluate the diagnostic performance of EPIPROBE TAGMe DNA Methylation Detection Kit for Urothelial CancerThe study aims to evaluate the diagnostic performance of the EPIPROBE TAGMe DNA Methylation Detection Kit for the detection of urothelial cancer. This assay utilizes targeted DNA methylation analysis to identify specific epigenetic alterations associated with urothelial malignancies. The performance of the kit will be assessed in terms of sensitivity, specificity, and overall diagnostic accuracy using clinical urine samples from a patient population with hematuria. | Diagnostic test | – |
Primary outcome
Diagnostic performance of DNA methylation test for urothelial carcinoma
Time frame: 2 weeks
Evaluate the diagnostic performance of EPIPROBE TAGMe DNA Methylation Detection Kit for Urothelial Cancer by calculating the sensitivity, specificity.
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 8 Apr 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by Shanghai Epiprobe Biotechnology Co., Ltd..
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Yaping Dong (86-18046043049, dongyaping@epiprobe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of DNA methylation test for urothelial carcinoma (time frame: 2 weeks). 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 8 Apr 2025.