Prediction of Lymph Node Status in Stage T1 Esophageal Squamous Cell Carcinoma（RENMIN-237）

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Other: no intervention

• Registration Number: NCT05980403
• Lead Sponsor: Yongshun Chen

Brief Summary

Accurate assessment of lymph node status in superficial esophageal squamous cell carcinoma is of great significance for preventing undertreatment and overtreatment. However, the accuracy of the commonly used preoperative imaging methods for evaluating lymph node status is not high, and it is urgent to develop a prediction model that can predict the risk of individual lymph node metastasis to assist in clinical decision-making. In this context, investigators intend to retrospectively collect the clinical and pathological data of 300 patients with superficial esophageal squamous cell carcinoma, construct a lymph node metastasis risk prediction model. In addition, investigators are also preparing to prospectively collect tissue samples from 30 patients with superficial esophageal squamous cell carcinoma to further explore the mechanism of lymph node metastasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-18
• Study First Submitted: 2023-07-21
• Study First Submitted QC: 2023-07-29
• Study First Posted: 2023-08-08
• Status Verified: 2024-01
• Primary Completion: 2024-01-18
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Study Completion: 2024-12-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Patients diagnosed with esophageal cancer in Renmin Hospital of Wuhan University from 2013 to 2022.
2. Histopathological diagnosis was squamous cell carcinoma.
3. T1NxM0.
4. Received endoscopic resection or esophagectomy.

Exclusion Criteria

1. Patients who received neoadjuvant therapy.
2. Positive surgical margin.
3. Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured.
4. Lack of complete histopathological information.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lymph node metastasis positive	no intervention	Superficial esophageal squamous cell carcinoma with positive lymph node metastasis

Primary Outcome Measures

Name	Time	Method
Lymphatic metastases	Through study completion, an average of 2 year	The primary end point was the presence of lymph node metastases in surgically resected specimens (≥ 15 resected lymph nodes), or the development of metastases during follow-up including local recurrence and distant metastasis (AJCC 8th). In cases of an endoscopic resection prior to surgical resection, the tumor was found in the endoscopic resection specimen and lymph node status in the surgical resection specimen. When no additional surgery was performed after endoscopic resection, the development of metastases during follow-up was used as a surrogate end point.

Trial Locations

Locations (1)

Renmin hosptial of Wuhan University; 🇨🇳 Wuhan, Hubei, China