Skip to main content
OpenTrials
Completed

NCT Number: NCT06871956

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

1 Friendship Road, Yuzhong District Chongqing

Chongqing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

PMRA and Shapley-Based Machine Learning for Predicting Lymph Node Metastasis in Central Subregions of Clinically Node-Negative Papillary Thyroid Microcarcinoma

Diagnostic Test

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

Primary outcomes

  1. 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.

    Time frame: 2016-2023

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Acronym: PMRA

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.