NCT03421015已完成不适用
Genomic Analysis in Localized or Locally Advanced Prostate Cancer. Identification of Biomarkers Predictive of Biochemical or Metastatic Recurrence
University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2017年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- The genetic alteration frequencies of TMPRSS2-ERG gene fusion
研究概览
简要总结
Developing a genetic study on localized or locally advanced prostate cancer. The aim of the study is to identify genomic alteration predictive of metastatic recurrence in the context of primary heterogeneity, by using the next generation sequencing (NGS) techniques.
Identifying such biomarkers may be useful to detect a higher relapse risk, and thus lower the mortality rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients managed by radical prostatectomy for prostate cancer between 2000 and
- •Follow up > 6 years
- •Negative pre surgical extension assessment
- •Prognostic Grade Groups (OGG) III-IV-V
- •Biochemical recurrence defined by 2 consecutive PSA rises ≥ 0,2 ng/mL
- •Metastasis positive imaging
排除标准
- •Neoadjuvant therapy
- •Follow up < 6 years
- •Prognostic Grade Groups (PGG) I-II
- •Biochemical recurrence with metastasis negative imaging
结局指标
主要结局
The genetic alteration frequencies of TMPRSS2-ERG gene fusion
时间窗: Baseline
次要结局
- Frequency of point mutations modifying protein function (SPOP)(Baseline)
- Frequency of mutations or deletions of tumor suppressor genes (PTEN, TP53, NKX3-1),(Baseline)
- Frequency of amplification of proto-oncogenes (MYC, AR, PIK3CA),(Baseline)
研究者
研究点 (2)
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