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临床试验/NCT06256185
NCT06256185已完成不适用

Machine Learning to Predict Lymph Node Metastasis in T1 Esophageal Squamous Cell Carcinoma: A Multicenter Study

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 1,267 人开始时间: 2010年1月15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
1,267
试验地点
1
主要终点
Sub-analysis (ML Model vs. Logistic Model vs. NCCN Guideline)

研究概览

简要总结

Existing models do poorly when it comes to quantifying the risk of Lymph node metastases (LNM). This study generated elastic net regression (ELR), random forest (RF), extreme gradient boosting (XGB), and a combined (ensemble) model of these for LNM in patients with T1 esophageal squamous cell carcinoma.

详细描述

Lymph node metastases (LNM) is a relatively uncommon but possible complication of T1 esophageal squamous cell carcinoma (ESCC). Existing models do poorly when it comes to quantifying this risk. This study aimed to develop a machine learning model for LNM in patients with T1 esophageal squamous cell carcinoma.

Patients with T1 squamous cell carcinoma treated with surgery between January 2010 and September 2021 from 3 institutions were included in this study. Machine-learning models were developed using data on patients' age and sex, depth of tumor invasion, tumor size, tumor location, macroscopic tumor type, lymphatic and vascular invasion, and histologic grade. Elastic net regression (ELR), random forest (RF), extreme gradient boosting (XGB), and a combined (ensemble) model of these was generated. Use Area Under Curve (AUC) to evaluate the predictive ability of the model. The contribution to the model of each factor was calculated. In order to better meet clinical needs, the investigators have designed the model as a user-friendly website.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • (I) thoracic ESCC
  • (II) no history of concomitant or prior malignancy
  • (III) tumor with pT1 staging
  • (IV) 15 or more lymph nodes examined

排除标准

  • underwent neoadjuvant treatment or endoscopic submucosal dissection before surgery

结局指标

主要结局

Sub-analysis (ML Model vs. Logistic Model vs. NCCN Guideline)

时间窗: 8 weeks

Apply NCCN guidelines and logistic models for prediction, and compare their performance with the model obtained in this study to determine the actual application benefits of the model

Model performance: discrimination

时间窗: 8 weeks

Draw the ROC curve of the model and obtain their AUC values, and select the best prediction model based on the results of the validation set

Variable importance

时间窗: 6 weeks

Calculate the importance level of variables used in the model and sort them, and analyze the reasons for the most important variables

次要结局

未报告次要终点

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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