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临床试验/NCT07351708
NCT07351708已完成不适用

Development and Validation of a Post-operative Risk Of Local Recurrence Model Integrating Serology and Evalution (PROMISE) in Local Advanced Rectal Cancer Receiving Neoadjuvant Therapy: a Multicenter Study

Cai Zerong0 个研究点目标入组 2,315 人开始时间: 2010年1月6日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,315

研究概览

简要总结

Local recurrence (LR) in locally advanced rectal cancer (LARC) correlated with poor survival and impaired quality of life. The aim of this study was to develop and validate machine learning (ML) models integrating clinicopathological features and inflammatory signature to predict LR in LARC patients undergoing neoadjuvant therapy followed by total mesorectal excision.

详细描述

To address the gap in accessible and integrative risk prediction, this study aimed to develop and validate an interpretable machine learning model for the early prediction of postoperative local recurrence in LARC patients using a multicenter cohort. We employed SHapley Additive exPlanations (SHAP) analysis to elucidate feature importance and provide clear interpretations for individual predictions, with the ultimate goal of evaluating the model's clinical utility in guiding personalized patient management-particularly by identifying high-risk patients in clinical practice and informing tailored follow-up and treatment strategies to improve patient outcomes.

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

  • Diagnosed cT>=3 or cN+ stage rectal cancer by pelvic MRI or enhanced CT scan;
  • Pathological proved primary rectal adenocarcinoma;
  • Recieved full-cource radiation or more than 3 cycles of chemotherapy before surgery;
  • Recieved radical tumor resection by TME surgery.

排除标准

  • Diganosed with any distant metastasis disease or locally unresectable disease before neoadjuvant treatment or surgery;
  • Recieved local resection surgery (R2 resection) or postoperative pathology confirmed positive surgical margins (R1 resection);
  • Patients who died due to intra- or post-operative complications;
  • Patient who die or relapse within 30 days after surgery;
  • Patients who had a prior history of malignancy within 5 years before surgery;
  • Patients who were loss of follow-up or had inadequate clinical data.

研究者

发起方
Cai Zerong
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cai Zerong

Deputy Director of the Department

Sixth Affiliated Hospital, Sun Yat-sen University

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