Evaluation of the Xpert® Bladder Cancer Monitor Assay Compared to Cystoscopy for the Follow-up of Patients With History of Low or Intermediate Risk Non-muscle-invasive Bladder Cancer (NMIBC): an Observational Prospective International Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cepheid
- 入组人数
- 852
- 试验地点
- 13
- 主要终点
- The primary endpoint is the comparison of the number of recurrences detected between the standard of care (cystoscopy) and a urine biomarker assay
研究概览
简要总结
Bladder cancer is the 5th most common cancer in Europe, with more than 151,000 new cases diagnosed in 2012 (4% of the total). Bladder cancer has the highest recurrence rate of any malignancy, often as high as 70% within 5 years of successful treatment. This high recurrence rate requires diligent and accurate monitoring as a means for early diagnosis and treatment. Considering the burden associated to repeated invasive cystoscopies, there is a need for robust but accurate tests for surveillance. In that prospect, urinary molecular tests have been developed although none were deemed adequate in the European clinical guidelines to replace cystoscopies. The Xpert Bladder Cancer Monitor Assay is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with this cancer. The test provides a fast and accurate result, is non-invasive and easy to perform. The aim of this study is to assess the non-inferiority of the Xpert Bladder Cancer Monitor assay in detecting recurrences in comparison to cystoscopy in the follow-up of patients with low or intermediate risk non-muscle-invasive bladder cancer (NMIBC).
详细描述
Patient recruitment and follow-up are closed. The study is in analysis phase.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing a follow-up cystoscopy at the time of enrolment for low or intermediate risk NMIBC patients in the follow-up phase (according to the 2017 EAU guidelines),
- •Patient must accept to be followed for 1 year after enrolment cystoscopy,
- •Patient who can provide urine samples naturally (e.g. no catheterization),
- •18 years or older at the time of enrolment,
- •Signed informed consent.
排除标准
- •Patient with history of NMIBC stratified at the time of enrolment as high risk according to 2017 EAU Guidelines,
- •Patient with history of Muscle-Invasive Bladder Cancer (MIBC),
- •Patient having undergone a TURB less than 3 months before enrolment,
- •Patient having received Mitomycin C (MMC) or Bacillus Calmette-Guerin (BCG) intravesical instillations less than 3 months before enrolment (a single MMC post-operative instillation is acceptable for inclusion).
结局指标
主要结局
The primary endpoint is the comparison of the number of recurrences detected between the standard of care (cystoscopy) and a urine biomarker assay
时间窗: 12 months from patient enrollment in the study.
The primary outcome measure is the ratio of patients presenting recurrence, comparing the number of patients with positive cystoscopies over the duration of 12 months to the number of patients with positive Xpert Bladder Cancer Monitor Assay at D0 (at enrollment).
次要结局
- Comparison of the number of positive and negative tests of Xpert Bladder Cancer Monitor and cystoscopy results at the time of each NMIBC follow-up assessment.(At each patient follow-up up to 12 months of study.)
- EuroQol Five Dimensions Questionnaire (EQ-5D-5L questionnaire) at Day 0(At patient enrollment)
- Patient numeric scale for cystoscopy discomfort(At each patient follow-up up to 12 months of study.)
- Comparison of the number of patients with negative Xpert Bladder Cancer Monitor assay results and the number of patients with negative cystoscopy results at D0 who are not presenting with recurrent bladder cancer within 12 months of enrolment cystoscopy.(12 months from patient enrollment in the study.)
- Assessment of medical care resources consumption related to bladder cancer at 1 month after each cystoscopy.(1 month after each cystoscopy through study completion.)
- EuroQol health visual analogue scale at Day 0.(At patient enrollment.)