Lymph Node Metastasis in Early Esophageal Squamous Cell Carcinoma

NCT ID: NCT07050576

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-11-30

Brief Summary

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This study aims to develop a predictive model using deep learning and radiomics to assess the likelihood of lymph node metastasis in patients with early-stage esophageal squamous cell carcinoma (ESCC). Lymph node metastasis is a critical factor in determining the treatment approach and prognosis for ESCC patients. By analyzing medical imaging data, we hope to create a non-invasive method that can assist doctors in making more accurate treatment decisions. This research could improve patient outcomes by enabling earlier and more tailored interventions.

Detailed Description

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Conditions

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ESCC Lymph Node Metastasis Radiomics

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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A

A total of 400 patients with early-stage ESCC from our center were divided into training and test sets.

The prediction model of lymph node metastasis in early esophageal squamous cell carcinoma

Intervention Type DIAGNOSTIC_TEST

The predictive performance of the model was validated in the test set. The optimal prediction model was determined based on the AUC and ACC. To assess the robustness of the chosen model, ROC analysis was conducted on the external validation set.

B

A total of 100 patients with early-stage ESCC from other center were defined as external validation

The prediction model of lymph node metastasis in early esophageal squamous cell carcinoma

Intervention Type DIAGNOSTIC_TEST

The predictive performance of the model was validated in the test set. The optimal prediction model was determined based on the AUC and ACC. To assess the robustness of the chosen model, ROC analysis was conducted on the external validation set.

Interventions

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The prediction model of lymph node metastasis in early esophageal squamous cell carcinoma

The predictive performance of the model was validated in the test set. The optimal prediction model was determined based on the AUC and ACC. To assess the robustness of the chosen model, ROC analysis was conducted on the external validation set.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with pathologically confirmed early-stage (T1) ESCC
* Preoperative contrast-enhanced CT data within 2 weeks before surgery
* Without any treatment before surgical resection

Exclusion Criteria

* Patients who underwent neoadjuvant therapy or endoscopic treatment
* Insufficient CT imaging or poor CT quality
* Incomplete pathology results
* Presence of metastatic disease
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hao Zheng, MD

Role: CONTACT

+86 139 1793 6873

Facility Contacts

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Hao Zheng, MD

Role: primary

+86 139 1793 6873

Other Identifiers

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Early-ESCC-LNM-2024

Identifier Type: -

Identifier Source: org_study_id

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