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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05980403
• Other study ID #: WDRY2023-K115
• Status: Recruiting
• Start date: July 18, 2023
• Est. completion date: September 18, 2024

Study information

• Verified date: January 2024
• Source: Renmin Hospital of Wuhan University
• Contact: Yongshun Chen, MD
• Phone: +8615327122084
• Email: yongshun2007[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 18, 2024
• Est. primary completion date: June 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Renmin hosptial of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Yongshun Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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