NCT03256630终止不适用
A Laboratory Study To Evaluate A Blood Biomarker That Can Distinguish Between the Presence Or Absence of Aggressive Prostate Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Characterize the distribution of clinical/pathological factors of the samples by the Gleason Grade Group and to characterize the distribution of the signal of each biomarker by the Gleason Grade Group or combination of groups.
研究概览
简要总结
A Laboratory Study to Evaluate Urine and Blood Biomarkers That Can Distinguish Between the Presence or Absence of Aggressive Prostate Cancer
详细描述
The over-arching goal of this study is to evaluate if biomarkers within the blood or urine of men with localized prostate cancer can distinguish between those with indolent cancer, defined as Gleason Grade Groups 1 and 2 and those with more aggressive disease (Gleason Grade Groups 3, 4, and 5).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient has been diagnosed with Prostate Cancer and is planning on having a Radical Prostatectomy performed at the Global Robotics Institute.
- •Diagnostic PSA ≤ 20 ng/mL.
- •Pathology report from most recent positive biopsy, prior to Radical Prostatectomy, is available.
- •Ability to read and understand the informed consent form.
- •Patient must have signed informed consent form
排除标准
- •Any of the following active therapies received: radiation, chemotherapy, biologic agents, surgery, local therapies including cryotherapy or HIFU.
- •Diagnostic PSA > 20 ng/mL or missing PSA.
- •Patients who are unable or unwilling to provide informed consent.
结局指标
主要结局
Characterize the distribution of clinical/pathological factors of the samples by the Gleason Grade Group and to characterize the distribution of the signal of each biomarker by the Gleason Grade Group or combination of groups.
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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