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

Sponsor

Yongshun Chen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05980403

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

49.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma	Other: no intervention

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Jul 18, 2023

Anticipated Primary Completion Date :

Oct 18, 2023

Anticipated Study Completion Date :

Jan 18, 2024

Arms and Interventions

Arm	Intervention/Treatment
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 no intervention

Arm

Intervention/Treatment

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

no intervention

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.