Establishment of the Performance of the miR Sentinel™ BCa Test in Men and Women Presenting for Initial Diagnosis of Bladder Cancer and the miR Sentinel™ BCR Test to Identify Recurrent Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- To establish the performance characteristics of the miR Scientific Sentinel™ Bladder Cancer Diagnostic Test (miR Sentinel™ BCa Test), a urine exosome-based diagnostic test, to identify bladder cancer in participants presenting with hematuria
研究概览
简要总结
The purpose of the study is to establish the clinical performance and utility of the miR Sentinel™ BCa Test, a urine exosome-based diagnostic test, as an aid in diagnosing bladder cancer. Male and female participants presenting with micro- or macro-hematuria who are undergoing cystoscopy for diagnosis of bladder cancer will be eligible for the study. Urine samples will be collected at the time of the first presentation, and the miR Sentinel™ BCa Score determined and compared to the results of cystoscopy. Participants with no evidence of cancer following cystoscopy will be designated cancer-free, while those participants with a positive cystoscopy and histopathological evidence of cancer will be designated as having bladder cancer. Participants with a positive cystoscopy who subsequently undergo TURBT will be eligible to continue in the study. Urine samples will be collected at each follow up visit for up to three years, and the miR Sentinal™ BCR Score will be determined and compared to the results of surveillance cystoscopy.
详细描述
Primary Objective(s):
Establish the performance characteristics of the miR Sentinel™ BCa Test as an aid in diagnosing bladder cancer in men and women presenting with hematuria.
Secondary Objective(s) Establish the performance characteristics of the miR Sentinel™ BCR Test in identifying bladder cancer patients with recurrent disease.
Study Design:
Participants who present with evidence of hematuria (micro- or macro-hematuria) and are scheduled to have cystoscopy will be enrolled. All participants will provide a urine sample for the miR Sentinel™ BCa Test prior to cystoscopy for bladder cancer. The presence or absence of cancer will be determined by cystoscopy. Diagnosis of bladder cancer will be confirmed by histopathology. The performance of the miR Sentinel™ BCa Test for classifying future patients as either bladder cancer or no bladder cancer will be established. The sensitivity, specificity, positive and negative predictive value determined for the miR Sentinel™ BCa Test and will be compared to cystoscopy.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between the ages of 45 and 85 years of age
- •Signed informed consent prior to initiation of any study-related procedures
- •Minorities are included in this protocol
- •Micro- or macro-hematuria
排除标准
- •Persons incapable of providing informed consent
- •Any person with a prior history of bladder cancer
- •For continued enrollment in the validation of the miR SentinelMales and females between the ages of 45 and 85 years of age BCR Test, previous malignancies including bladder cancer, treatment with chemotherapeutic of immunotherapeutic agents
- •Persons with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome
结局指标
主要结局
To establish the performance characteristics of the miR Scientific Sentinel™ Bladder Cancer Diagnostic Test (miR Sentinel™ BCa Test), a urine exosome-based diagnostic test, to identify bladder cancer in participants presenting with hematuria
时间窗: Urine samples will be collected from participants at the time of entry and analyzed immediately for the miR Sentinel™ BCa test. Additional urine samples will be collected and analyzed at each follow-up visit up to 1 year.
The miR Sentinel™ BCa test is an in-vitro urine exosome-based diagnostic test. The test measures up to 280 sncRNA present in urine exosomes and produces a dichotomized assessment of "-1" (no cancer) and "+1" (cancer) based on the expression profiles of the exosomal sncRNAs As outlined in detail in the statistical analysis of the description, among the 3000 participants (1500 males; 1500 females) enrolled, it is anticipated that 2600 (1275 males; 1325 females) will have a Sentinel™ BCa Score of "-1", indicative of no cancer , and 400 (225 males; 175 females) will have a Sentinel™ BCa Score of "+1", indicative of cancer. Concordance and discordance between the final Sentinel™ BCa Score and the histopathology reports of biopsy and cystoscopy results will be used to determine the sensitivity, specificity, positive and negative predictive values of the test.
次要结局
- Validate the performance characteristics of the miR Scientific Sentinel™ Bladder Cancer Recurrence Test (miR Sentinel™ BCR Test) for the identification of recurrent disease in a longitudinal study(Urine samples will be collected from participants at entry, prior and post TURBT, given the miR Sentinel™ BCa test is "+1". Additional urine samples will be collected and analyzed at each follow-up visit, up to three years.)