Non-invasive urine test to screen for urothelial cancer in adults with blood in urine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-stage, prospective, single-center observational study that tests urine-based biomarkers to diagnose urothelial carcinoma using histopathology as the reference standard. Stage 1 enrolled 113 adults and used four urine tests (cytology, FISH, DNA methylation, and a 17-gene mutation panel). Stage 2 concentrates on a urine DNA methylation test alone to reduce cost and simplify the approach, with ongoing enrollment and data collection. The study aims to determine the diagnostic accuracy of noninvasive urine testing to help guide subsequent tissue diagnostic procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients are eligible if they meet all of the following criteria:

1. Age ≥ 18 years.
2. Presence of gross or microscopic hematuria.
3. Imaging (B-ultrasonography, CT, or MRI) showing a renal pelvic, ureteral, or bladder lesion.
4. Scheduled for surgery for tissue histopathological diagnosis.
5. Able to provide written informed consent.

Exclusion Criteria

1. Inadequate urine sample (poor quality or insufficient volume).
2. Lack of final histopathological diagnosis.

Where it's running

• Henan Provincial People's Hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Principal investigator: Zhifeng Wang, PhD — Henan Provincial People's Hospital
• Study coordinator: Kunpeng Shu
• Email: kunpengshu@163.com
• Phone: +8615515696659

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Urinary Cell-Free DNA Test for Urothelial Cancer Origin

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  Recruiting AZ Sint-Lucas Gent · Ghent, East Flanders · NCT07756437

• Combination treatment for HER2-positive upper tract urothelial carcinoma after surgery

  This study is testing a new combination of targeted therapy and immune treatment to see if it helps prevent cancer from coming back in patients with HER2-positive upper tract urothelial carcinoma after surgery.

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• BL-M07D1: T-bren vs standard platinum chemo for HER2-expressing metastatic urothelial cancer after anti-PD-(L)1 therapy

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  Recruiting at 2 sites Phase 3 SystImmune Inc. · Macon, Georgia and 1 other locations · NCT07869836

• Urine test to detect urological cancers in people with blood in urine

  This study tests whether a urine fluorescence test can help find urological cancers in adults with hematuria before biopsy.

  Recruiting Ruijin Hospital · Shanghai · NCT07813260

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.