Study on Risk Assessment for Patients With Microscopic Hematuria (Non-Visible Blood in Urine) Using a Urine Marker Test

Официальное название

Risk Stratification of Patients With Non-Visible Hematuria - A Prospective Validation Study Using a Urine Marker-Based Assessment (Xpert® Bladder Cancer Detect)

Обзор

The goal of this clinical study is to learn how well a urine test called Xpert® Bladder Cancer Detect (Xpert BC-D) can help doctors assess the risk of bladder cancer in people with non-visible blood in their urine (microscopic hematuria). The main questions it aims to answer are: * Can the Xpert BC-D test accurately identify people at higher risk for bladder cancer? * Can combining the test results with other clinical information improve risk assessment compared to standard evaluation methods? Participants will: * Have leftover urine from the routine initial evaluation tested with the Xpert® Bladder Cancer Detect assay * Complete questionnaires about urinary symptoms using the modified IPSS and ICIQ-FLUT-S forms * Attend a first visit for medical evaluation and cystoscopy * Attend a follow-up visit 3 to 6 months later for additional testing and questionnaires This study includes adults over 40 years of age who have had microscopic hematuria detected within the past six months. People with a history of bladder cancer, urinary tract surgery, or certain other medical conditions, as well as individuals who are currently pregnant, cannot participate. The study will be conducted at 20-24 sites in Germany and Austria and will last approximately 27 months, with each participant involved for about 6 months. The results of this study may help doctors better decide which patients need further invasive testing, potentially reducing unnecessary procedures.

Первичные конечные точки

• Validating results of a recent metanalysis (UroDetect II) achieving an overall sensitivity of the Xpert BC-D for UCas of >0.70 and a specificity of >0.65 [Срок оценки: From enrollment until completion of follow-up at 6 months]

Вторичные конечные точки (7)

• Effective detection of high impact tumors (HITs, defined as Ta G3/HG, CIS, and ≥T1 urothelial cancer) [Срок оценки: From enrollment until completion of follow-up at 6 months]
• Validating results from a recent meta-analysis demonstrating improved risk stratification by combining the Xpert BC-D results with clinical parameters [Срок оценки: From enrollment until completion of follow-up at 6 months]
• Simulating application of current major guideline recommendations, a significantly better discrimination between patients at low/high risk for subsequent UCa diagnosis for: The Xpert BC-D results and combinations from Xpert BC-D results and clinical [Срок оценки: From enrollment until completion of follow-up at 6 months]
• Cost-benefit considerations (based on structured information e.g. from GOÄ and EBM) [Срок оценки: From enrollment until completion of follow-up at 6 months]
• Investigating the rate of negative TUR-Bs triggered by standard-of-care (SOC) vs. positive findings by Xpert BC-D results and respective combination with clinical results. (study not powered for confirmation of a significant difference) [Срок оценки: From enrollment until completion of follow-up at 6 months]
• Prospective assessment of symptoms of nvH patients (assessment using modified versions of ICIQ-FLUTS and IPSS) [Срок оценки: From enrollment until completion of follow-up at 6 months]
• Investigating the frequency of conditions requiring medical and/or surgical intervention resulting from nvH assessment [Срок оценки: From enrollment until completion of follow-up at 6 months]

Критерии участия

Критерии включения

• Signed consent form after being informed about the study
• Willing and able to follow the study requirements
• Non-visible blood in the urine, found within the past 6 months
• Age over 40 years

Критерии исключения

• Previous diagnosis of bladder cancer
• Too much protein in the urine (shown by urine test)
• Current urinary tract infection (symptoms like pain or frequent urination, plus bacteria found in urine test)
• Current pain in the urinary tract or lower belly, pain score greater than 2 on a 0-10 scale
• Signs of kidney-related blood in the urine (found by special urine test)
• Bladder examination with a camera (cystoscopy) within the past 12 months
• Pregnancy
• Visible blood in the urine within the past year
• Previous surgery on the urinary tract
• Previous radiation treatment to the pelvic area
• Permanent tube or foreign body in the urinary tract (such as a catheter)
• Participation in another clinical study at the same time or within 30 days before this study
• Detained under legal or official authority
• Medical, psychological, or social problems that would make it hard to follow the study requirements
• Not able to understand the study information well enough to give consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• Urology and Pediatric Urology University Hospital Ulm — Ulm

Идентификаторы

NCT: NCT07307300 · UroDetect III

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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