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

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Fudan University

Status

Completed

Conditions

Lymph Node Metastasis

Treatments

Procedure: esophagectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06256185
81902396

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,267 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,267 participants in 1 patient group

Arm used for predicting lymph node metastasis
Experimental group
Treatment:
Procedure: esophagectomy

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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