An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients

Myriad Genetic Laboratories, Inc.0 个研究点目标入组 1,270 人开始时间: 2013年4月最近更新: 2015年6月2日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Myriad Genetic Laboratories, Inc.
入组人数: 1,270
主要终点: Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option implemented following results of genomic risk assessment testing (Prolaris®).

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This registry is intended to evaluate the impact of genomic test results towards selecting a first-line therapy option for newly diagnosed localized prostate cancer patients.

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: Male
接受健康志愿者: 否

入选标准

•Newly diagnosed (≤6 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics.
•Clinically localized (no evidence on clinical or imaging studies of advanced disease).
•No hormonal therapy including LHRH (luteinizing hormone-releasing hormone) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable.
•Sufficient amount of tissue remains from biopsy to perform genomic testing.

排除标准

•Patients with a known history of hypogonadism

结局指标

主要结局

Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option implemented following results of genomic risk assessment testing (Prolaris®).

时间窗: 4 months

次要结局

Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following review of the genomic test results (prior to patient consultation)(1 month)
Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following consultation with the patient.(2 months)

研究者

发起方

Myriad Genetic Laboratories, Inc.

申办方类型

Industry

责任方

Sponsor

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