NCT02209584已完成不适用
An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients by Specialists
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option of genomic risk assessment testing (Prolaris®).
研究概览
简要总结
This registry is intended to measure the impact of Prolaris® testing on therapeutic decisions when added to standard clinical-pathological parameters in men with newly diagnosed prostate cancer.
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 agonist or antagonist, anti-androgen, 5-alpha reductase inhibitor, estrogens or exogenous androgens, when applicable.
- •Sufficient amount of tissue remains from biopsy to perform genomic testing.
排除标准
- •Patients with known history of hypogonadism will be excluded from the registry
结局指标
主要结局
Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option of genomic risk assessment testing (Prolaris®).
时间窗: 1 months
次要结局
- Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan (prior to patient consultation).(1 month)
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
Registry to Measure the Impact of Adding Genomic TestingProstate CancerNCT02454595Myriad Genetic Laboratories, Inc.116
已完成
不适用
Open Registry Measuring Impact of Genomic Testing on Treatment of Prostate Cancer PatientsProstate CancerNCT01954004Myriad Genetic Laboratories, Inc.1,270
已完成
3 期
Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic LeukemiaLeukaemiaNCT01313689Novartis Pharmaceuticals122
Unknown
不适用
Pharmacogenomics Registry to Assess Clinical UtilityDrug Side EffectsNCT02374840Companion Dx Reference Lab, LLC340,778
已完成
3 期
Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's DiseaseModerate and Severe Active Rheumatoid ArthritisActive Psoriatic ArthritisActive Ankylosing SpondylitisModerately to Severely Active Crohn's DiseaseNCT03357471UCB Biopharma S.P.R.L.70