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临床试验/NCT04063800
NCT04063800已完成不适用

Prediction of the Risk of Biochemical Relapse After Radical Prostatectomy for Prostate Cancer Using Radomics on Pre-therapeutic MRI

University Hospital, Brest2 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2018年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
195
试验地点
2
主要终点
Prediction of biochemical failure

研究概览

简要总结

With 50% of post-operative biochemical failure, efficient predictive models are needed to guide post-operative management.

Radiomic features are quantitative features extracted from medical imaging, supposed to be correlated with tumor heterogeneity.

We aim to build and test three predictive models (clinical, radiomic and combined models).

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
Male
接受健康志愿者

入选标准

  • Age > 18yo
  • Patients underwent radical prostatectomy
  • High-risk prostate cancers: at least 1 criteria (pt3a/pT3b/pT4, R1, Gleason score > 7)

排除标准

  • No available pre-operative MRI
  • No analyzable pre-operative MRI
  • proof of lymph-node involvement (cN1/2 or pN1/2)
  • post-operative PSA > 0.04ng/mL

结局指标

主要结局

Prediction of biochemical failure

时间窗: From the date of surgery until data collection (up to 100 months)

Comparison of AUCs between each predictive model

次要结局

  • Prediction of survival without biochemical failure(From the date of surgery until data collection (up to 100 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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