Urine test to detect urological cancers in people 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 prospective, single-center diagnostic study enrolling adults with hematuria who are scheduled for cystoscopy or ureteroscopy. Each participant provides a urine sample before endoscopy, which is tested with an immunofluorescence assay and DNA ploidy analysis, then compared to the biopsy/histopathology results. The goals are to estimate how well the urine test correctly identifies cancer (sensitivity), correctly identifies non-cancer (specificity), and the chance of a negative result when cancer is absent (negative predictive value). Secondary analyses include comparing the two index tests and measuring agreement with the reference standard. The study aims to enroll 170 participants to determine diagnostic accuracy for urothelial cancers including bladder, renal pelvis, and ureteral cancers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Presenting with hematuria requiring urological malignancy workup

Age ≥ 18 years

Planned to undergo cystoscopy and/or ureteroscopy

Able to provide written informed consent

Exclusion Criteria:

* Prior confirmed diagnosis of urological malignancy

Participation in another clinical trial within 3 months prior to enrollment

Any clinical condition that, per investigator judgment, may interfere with study execution

Inadequate urine sample quality or volume

Where it's running

• Ruijin Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Hai Huang
• Email: hh12295@rjh.com.cn
• Phone: china+18817875498

Similar studies

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

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

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• Monitoring recurrence of urothelial carcinoma using urinary tests

  This study is testing if urine tests can help track the return of urothelial carcinoma in patients with different types of bladder and kidney cancer.

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• Single chemotherapy instillation after ureteroscopy for UTUC

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

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  Recruiting Phase 2 Jinling Hospital, China · Nanjing, Jiangsu · NCT05917158

• Urinary Cell-Free DNA Test for Urothelial Cancer Origin

  This study tests a urine-based cell-free DNA test to help diagnose urothelial cancer and identify whether it started in the bladder or upper urinary tract in adults.

  Recruiting Ruijin Hospital · Shanghai · NCT07888374

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.