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Screening for Urological Malignancies Using a Urine Exfoliated Cell Fluorescence Assay in a Hematuria Population

Recruitingn/aAges 18 Years - anyAllRuijin Hospital
NCT07813260 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a prospective, single-center diagnostic clinical study designed to evaluate the performance of a urine-based immunofluorescence cytology test for the detection of urological malignancies in patients presenting with hematuria. The study will enroll 170 eligible participants who are scheduled for cystoscopy and/or ureteroscopy. Urine samples will be collected prior to endoscopy and subjected to both the index immunofluorescence assay and DNA ploidy analysis, with the results compared against the reference standard of endoscopic biopsy and histopathology. The primary objective is to estimate the sensitivity, specificity, and negative predictive value of the immunofluorescence test. Secondary objectives include evaluating the diagnostic accuracy of DNA ploidy analysis, comparing the two index tests using paired statistical methods (e.g., McNemar's test), and assessing their agreement

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Ruijin Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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