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Machine Learning to Predict Lymph Node Metastasis in T1 Esophageal Squamous Cell Carcinoma

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06256185
Enrollment
1267
Registered
2024-02-13
Start date
2010-01-15
Completion date
2023-07-15
Last updated
2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymph Node Metastasis

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREesophagectomy

Resection of esophageal tumor and lymph node dissection

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* underwent neoadjuvant treatment or endoscopic submucosal dissection before surgery

Design outcomes

Primary

MeasureTime frameDescription
Model performance: discrimination8 weeksDraw 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 importance6 weeksCalculate the importance level of variables used in the model and sort them, and analyze the reasons for the most important variables
Sub-analysis (ML Model vs. Logistic Model vs. NCCN Guideline)8 weeksApply 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026