Tokyo, Sept. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062899) titled 'A Comparative Study of Methods for Detecting Urothelial Cancer Using Urine Cells' on Sept. 14.

Study Type: Observational

Primary Sponsor: Institute - Kansai Medical University

Condition: Condition - Urothelial carcinoma or suspected urothelial carcinoma Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study will enroll patients with suspected urothelial carcinoma and patients with other urological diseases, including prostate cancer, renal cancer, benign prostatic hyperplasia, and urinary stones, all of whom present with microscopic or gross hematuria. We will compare the diagnostic performance of conventional urine cytology using spontaneously voided urine with that of ex vivo prepared urine cytology, which is generated by applying a proprietary optimized preparation procedure to rare exfoliated cells in voided urine. This study is designed as a Validation Phase study to demonstrate the clinical validity of this technology in a real-world hematuria cohort, using the protocol established in the preceding Development Phase without any modification. Cytological assessment will be conducted by evaluators who are fully blinded to clinical information. The objective is to confirm the usefulness of this method as a novel, minimally invasive pathological diagnostic system for urothelial carcinoma. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who meet all of the following criteria will be included in this study: 1.Patients who are 18 years of age or older at the time of consent, regardless of sex. 2.Patients in whom gross or microscopic hematuria has been confirmed by recent examination. 3.Patients who are scheduled to undergo imaging studies, transurethral endoscopic evaluation and/or procedures, or surgery for the evaluation or treatment of urothelial carcinoma. 4.Patients who have received sufficient explanation regarding participation in this study, have fully understood the study, and have provided written informed consent of their own free will. 5.Patients who have been informed of their disease name and clinical condition, have the capacity to provide consent, and have provided written informed consent. Key exclusion criteria - Patients who meet any of the following criteria will not be included in this study:

1.Patients who are considered unable to provide informed consent due to dementia, psychiatric disorders, or other conditions. 2.Patients with metastatic urothelial carcinoma who were diagnosed based only on urine cytology and imaging studies, without pathological confirmation. 3.Patients who are otherwise judged by the principal investigator to be inappropriate for Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 05 Day Date of IRB - 2026 Year 08 Month 05 Day Anticipated trial start date - 2026 Year 08 Month 05 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070813

Disclaimer: Curated by HT Syndication.