NCT00975455已完成不适用
Phase 3 Study of Hematuria Evaluation
Predictive Biosciences13 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2009年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,400
- 试验地点
- 13
- 主要终点
- To establish the performance characteristics of the Predictive Biosciences Assay relative to the cystoscopy results for subjects undergoing evaluation for the referral diagnosis of gross or microscopic hematuria
研究概览
简要总结
The purpose of the study is to evaluate subjects with gross or microscopic hematuria undergoing scheduled cystoscopy to determine the absence or presence of bladder cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For those subjects for whom there is no family history of bladder cancer or less than a 20 pack year history of cigarette smoking, subject must be 50 or older.
- •Subject's age can be lowered to 45 or older if there is a family history of bladder cancer and/or a 20 or greater pack history of cigarette smoking.
- •Subject must have an intact bladder
- •Subject must be scheduled to have a cystoscopy to screen for transitional call bladder cancer due to the finding of hematuria.
- •Subject must be able to provide a minimum of 25 mL of urine for study purposes.
- •Urine samples must be available prior to cystoscopy, bladder biopsy, and TUR.
- •Subjects must be willing to sign an Institutional Review Board approved written informed consent prior to any study related procedures being performed.
排除标准
- •Subject had a history or current diagnosis of any basal or squamous cell cancer.
- •Subject had a known diagnosis of any autoimmune disease.
- •Subject had known diagnosis of HIV, HCV or HBV
- •Subject had disclosed voluntarily history of or current infection with TB or other systemic disease.
- •Subject is currently pregnant or lactating.
- •Subject had surgery within 30 days prior to enrollment
- •Subject has known allergy to benzalkonium chloride.
- •Subject participated in an investigational drug or device trial within 30 days prior to enrollment.
结局指标
主要结局
To establish the performance characteristics of the Predictive Biosciences Assay relative to the cystoscopy results for subjects undergoing evaluation for the referral diagnosis of gross or microscopic hematuria
时间窗: Initial Visit only
次要结局
- To establish the performance characteristics of the PB assay relative to urine cytology results for subjects undergoing evaluation for the referral diagnosis of gross or microscopic hematuria.(Initial Visit)
研究者
研究点 (13)
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