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临床试验/NCT06871956
NCT06871956已完成不适用

PMRA and Shapley-Based Machine Learning for Predicting Lymph Node Metastasis in Central Subregions of Clinically Node-Negative Papillary Thyroid Microcarcinoma: a Prospective Multicenter Validation and Development of a Web Calculator

First Affiliated Hospital of Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 4,882 人开始时间: 2016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
4,882
试验地点
1
主要终点
Predictors were analyzed after the data of 1953 patients were included in the training set and internal validation (at a ratio of 7:3), and the predictors were analyzed in 286 patients and 176 patients, respectively, in two external validation centers.

研究概览

简要总结

Background:Management of clinically node-negative(cN0) papillary thyroid microcarcinoma (PTMC) is complicated by high occult lymph node metastasis (LNM) rates. We aimed to develop and validate a prediction model for central LNM using machine learning (ML) and traditional nomograms through Probability-based Ranking Model Approach (PMRA).

Methods: We conducted a prospective multicenter study involving 4,882 patients across 3 hospitals (2016-2023). After applying inclusion criteria, 1,953 patients from the primary center were allocated to model train and test (7:3 ratio). External validation included prospective cohorts of 286 and 176 patients from two independent centers.13 ML algorithms and traditional nomogram models were systematically evaluated using PMRA.We compared models using preoperative features alone versus those incorporating both preoperative and intraoperative frozen section pathology data. Feature selection utilized six methods, with L1-based selection proving optimal for most predictions.Model interpretability was enhanced through SHapley Additive exPlanations (SHAP) visualization.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • First-time thyroid cancer surgery patients
  • cN0-PTMC patients diagnosed through fine-needle aspiration and imaging.

排除标准

  • Secondary surgery
  • Other pathological types of thyroid cancer
  • Incomplete clinical data
  • Distant metastasis or history of cervical radiation exposure.

结局指标

主要结局

Predictors were analyzed after the data of 1953 patients were included in the training set and internal validation (at a ratio of 7:3), and the predictors were analyzed in 286 patients and 176 patients, respectively, in two external validation centers.

时间窗: 2016-2023

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital of Chongqing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xinliang Su

Chief Physician

First Affiliated Hospital of Chongqing Medical University

研究点 (1)

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