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Non-invasive Urinary Genomics-Based Risk Assessment for Early Urothelial Carcinoma Diagnosis

Recruitingn/aAges 18 Years - anyAllHenan Provincial People's Hospital
NCT07614594 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a two-stage, prospective, single-center observational diagnostic accuracy study evaluating noninvasive urine testing for the detection of urothelial carcinoma (UC). The study enrolls adult patients presenting with gross or microscopic hematuria and imaging evidence of a space-occupying lesion in the renal pelvis, ureter, or bladder, who are scheduled for diagnostic cystoscopy and/or surgical tissue sampling. Histopathological examination serves as the reference standard. Stage 1 (Completed, 8th October 2019 - 31st December 2023): A total of 113 participants have been enrolled. Owing to sufficient research funding, all participants in this stage underwent four urine-based tests: cytology, fluorescence in situ hybridization (FISH), DNA methylation, and a 17-gene mutation panel. Stage 2 (Ongoing, from 1st January 2024): The testing protocol was refined to focus on urine DNA meth

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
Henan Provincial People's Hospital
Zhengzhou, 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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