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Prediction of Lymph Node Invasion for Prostate Adenocarcinoma (PRED-NCHIR)

2022年1月17日更新者：University Hospital, Brest

Prediction of Lymph Node Invasion in Patients Operated on for Prostate Adenocarcinoma

Despite lymph node involvement (LNI) being one of the main prognostic factors in patients with prostate cancer (PCa), pelvic lymph node irradiation remains debated, possibly due to an insufficient selection of patients. Significant advances in LNI risk modelling have been achieved with the addition of visual interpretation of magnetic resonance imaging (MRI) data, but it is likely that quantitative analysis could further improve prediction models. In this study, the investigators aimed to develop and internally validate a novel LNI risk prediction model based on radiomic features extracted from pre-operative multimodal MRI.

研究概览

地位

招聘中

条件

前列腺癌

研究类型

观察性的

注册 (预期的)

400

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Ulrike Ulrike Schick
电话号码：+33298223398
邮箱：ulrike.schick@chu-brest.fr

学习地点

法国
- - Brest、法国、29200
    - 招聘中
    - CHRU Brest
    - 接触：
      
      Ulrike Schick, MD, PhD
      
      电话号码：+33298223398
      
      邮箱：ulrike.schick@chu-brest.fr

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

取样方法

概率样本

研究人群

The population consists of patients operated on for an adenocarcinoma of the prostate by radical prostatectomy with extensive lymph node dissection and for whom pre-operative MRI is available and analyzable.

描述

Inclusion Criteria:

Histologically proven adenocarcinoma of the prostate treated by prostatectomy with extensive lymph node dissection
Available pre-operative +/- PET choline

Exclusion Criteria:

Unanalyzable pre-operative MRI

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Absence of invaded lymph node after extensive lymph node dissection
Presence of invaded lymph node after extensive lymph node dissection

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Predicted risk of lymph-node involvement vs Briganti 2017 大体时间：immediately after the intervention/procedure/surgery	Comparison between the predicted risk of lymph node involvement based on the new algorithm and the predicted risk with the Briganti 2017	immediately after the intervention/procedure/surgery

次要结果测量

结果测量	措施说明	大体时间
Predicted risk of lymph-node involvement vs Briganti 2012, Briganti 2018, Briganti 2019 and MSKCC 大体时间：immediately after the intervention/procedure/surgery	Comparison between the predicted risk of lymph node involvement based on the new algorithm and the predicted risk with the Briganti 2012, Briganti 2018, Briganti 2019 and MSKCC	immediately after the intervention/procedure/surgery
Biochemical recurrence free survival 大体时间：immediately after the intervention/procedure/surgery	Prediction of Biochemical recurrence free survival	immediately after the intervention/procedure/surgery
Extra-prostatic disease 大体时间：immediately after the intervention/procedure/surgery	Prediction of Extra-prostatic disease	immediately after the intervention/procedure/surgery
Seminal vesicle invasion 大体时间：immediately after the intervention/procedure/surgery	Prediction of Seminal vesicle invasion	immediately after the intervention/procedure/surgery
Automatic segmentation of the index lesion 大体时间：immediately after the intervention/procedure/surgery	Comparison between a manual segmentation of the index lesion and an automatic segmentation	immediately after the intervention/procedure/surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Brest

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年1月1日

初级完成 (预期的)

2022年11月30日

研究完成 (预期的)

2022年11月30日

研究注册日期

首次提交

2021年1月26日

首先提交符合 QC 标准的

2021年6月1日

首次发布 (实际的)

2021年6月2日

研究记录更新

最后更新发布 (实际的)

2022年1月19日

上次提交的符合 QC 标准的更新

2022年1月17日

最后验证

2022年1月1日