Performance Evaluation of a Urine-based Methylation Assay for Urothelial Carcinoma

Launched by SHANGHAI EPIPROBE BIOTECHNOLOGY CO., LTD. · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to detect urothelial carcinoma (UC), which is a type of cancer that affects the urinary system. Traditionally, doctors diagnose UC through tests that can be invasive and uncomfortable, especially if a patient has blood in their urine (a condition called hematuria). The researchers want to see if a urine test that checks for specific changes in DNA (called methylation) can effectively and safely identify UC without needing invasive procedures.

To participate in this study, you need to be between 18 and 90 years old and have either visible blood in your urine or blood that can only be seen under a microscope. You'll need to provide enough urine for testing before any surgery and agree to participate by signing a consent form. However, if you have a history of any kind of cancer, severe urinary infections, or certain medical conditions, you may not be eligible. If you join this trial, you can expect to provide a urine sample which will be analyzed to help determine if this new test is a good option for detecting UC early.

Gender

ALL

Eligibility criteria

• 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.