Performance Evaluation of a Urine-based Methylation Assay for Urothelial Carcinoma (UMT-UC)

April 6, 2025 updated by: Shanghai Epiprobe Biotechnology Co., Ltd.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1500

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

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

Probability Sample

Study Population

The initial population suspected of having urothelial carcinoma with hematuria

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Collaborators and Investigators

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

Sponsor

Shanghai Epiprobe Biotechnology Co., Ltd.

Collaborators

Changhai Hospital
RenJi Hospital
Tongji Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First Hospital of China Medical University

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 (Estimated)

May 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 6, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPI-UC-2025-01

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

product manufactured in and exported from the U.S.

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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