NCT07307300尚未招募不适用
Risk Stratification of Patients With Non-Visible Hematuria - A Prospective Validation Study Using a Urine Marker-Based Assessment (Xpert® Bladder Cancer Detect)
Christian Bolenz1 个研究点 分布在 1 个国家目标入组 1,475 人开始时间: 2026年3月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,475
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
时间窗: From enrollment until completion of follow-up at 6 months
次要结局
- Effective detection of high impact tumors (HITs, defined as Ta G3/HG, CIS, and ≥T1 urothelial cancer)(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(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(From enrollment until completion of follow-up at 6 months)
- Cost-benefit considerations (based on structured information e.g. from GOÄ and EBM)(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)(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)(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(From enrollment until completion of follow-up at 6 months)
研究者
Christian Bolenz
Prof. Dr. med. Christian Bolenz
University Hospital Ulm
研究点 (1)
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