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

NCT05980403 | Unknown DMC

• 1 other identifier: WDRY2023-K115
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

superficial esophageal squamous cell carcinoma; lymph node metastasis; prediction model; tumor- infiltrating immune cells

Outcome Measures

Primary Outcomes (1)

• Lymphatic metastases

  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.

  Through study completion, an average of 2 year

Study Arms (2)

Lymph node metastasis negative

Superficial esophageal squamous cell carcinoma with negative lymph node metastasis

Lymph node metastasis positive

Superficial esophageal squamous cell carcinoma with positive lymph node metastasis

Other: no intervention

Interventions

no intervention OTHER

no intervention

Lymph node metastasis positive

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with superficial esophageal squamous cell carcinoma who underwent endoscopic therapy or esophagectomy.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yongshun Chen: lead

Study Sites (1)

Renmin hosptial of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue samples

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yongshun Chen, MD

CONTACT

+8615327122084; yongshun2007@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 8, 2023
• Study Start: July 18, 2023
• Primary Completion: January 18, 2024
• Study Completion: December 18, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-01

Locations

CN (1)