跳至主要内容
临床试验/NCT06314750
NCT06314750已完成不适用

Deep Learning Based MRI Radiomics in Predicting the Clinical Risk of Locally Advanced Rectal Cancer

Sixth Affiliated Hospital, Sun Yat-sen University0 个研究点目标入组 186 人开始时间: 2010年1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
186
主要终点
OS

研究概览

简要总结

Neoadjuvant therapy is the standard diagnosis and treatment strategy for locally advanced rectal cancer defined by MRI in order to achieve tumor regression, thus affecting the selection of surgical strategy and circumferential margin, improving the safety of operation and the prognosis of patients. This study focused on the related clinical factors such as tumor regression before and after neoadjuvant therapy, combined with preoperative high-dimensional features such as radiomics, to predict the related factors of tumor regression of locally advanced rectal cancer, and validate it with multicenter. In order to develop an accurate model that can be applied to the real world and stratify the risk of locally advanced rectal cancer patients before treatment.

详细描述

The patients with locally advanced rectal cancer were collected retrospectively, and the relevant information such as clinical baseline characteristics, imaging data and preoperative/postoperative pathological data were collected and integrated, applying the method of deep learning to construct the model, in order to predict and evaluate the risk factors (invasion of mesorectal fascia, status of cancer nodule, long-term prognosis, tumor recurrence, etc.) which are important in clinical diagnosis and treatment. After the model was established, prospective studies were carried out to validate the model, continue training and enrich the effectiveness of the model.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary rectal adenocarcinoma was diagnosed before operation
  • Preoperative MRI staging was diagnosed as stage cT4 rectal cancer
  • Receiving neoadjuvant therapy before operation (including but not limited to chemotherapy, radiotherapy, immunotherapy or targeted therapy, etc.)
  • Middle and low rectal cancer (the distance between the lower margin of the tumor and the anal margin ≤ 12cm measured by MRI)
  • Receive radical resection of rectal cancer

排除标准

  • lack of clinical TNM staging information or other key clinical information about MRI
  • the imaging quality is poor or the MRI image has artifacts

结局指标

主要结局

OS

时间窗: From date of randomization until the date of death from any cause, assessed up to 120 months

Overall Survival

次要结局

未报告次要终点

研究者

发起方
Sixth Affiliated Hospital, Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cai Zerong

Deputy Director of the Department

Sixth Affiliated Hospital, Sun Yat-sen University

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