Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Shanghai Epiprobe Biotechnology Co., Ltd.

Collaborating Sponsors:

Changhai Hospital

RenJi Hospital

Conditions:

Urothelial Carcinoma

Eligibility:

All Genders

18-90 years

Brief 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 methylati...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

1500 Patients enrolled

Trial Details

Trial ID

NCT06912672

Start Date

May 1 2025

End Date

December 31 2026

Last Update

April 8 2025

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