Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria

Launched by CHANGHAI HOSPITAL · Jun 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new urine test that looks for changes in DNA to help detect urothelial carcinoma, a type of cancer affecting the urinary system, in patients who have blood in their urine (a condition called hematuria). The goal is to see how accurately this urine test can identify cancer compared to standard diagnostic methods, which can be more invasive and uncomfortable. Researchers also want to find out if the test results can help predict how well patients will do after their treatment.

To participate in the trial, you need to be between 18 and 99 years old and have blood in your urine. You'll need to provide a urine sample before surgery and agree to take part in the study. The trial will involve collecting and testing your urine, but it’s designed to be non-invasive, meaning no surgery is required just for the test. This exciting new approach aims to improve cancer detection and potentially lead to better outcomes for patients. If you have any questions or think you might be eligible, please reach out to the study team for more details.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged between 18 and 99 years, with gross or microscopic hematuria (RBC ≥ 3 /HPF or RBC \> 18 /μL for men, \> 33 /μL for women).
• • Able to provide 50ml 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 UC).
• • 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.
• • Patients who did not undergo surgical treatment for various reasons.
• • 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.