Cohort study on early esophageal cancer patients

Development and Validation of a Curability Evaluation Model for Endoscopic Resection of Early Esophageal Squamous Cell Carcinoma Based on China Early Esophageal Cancer Cohort

This study is trying to find out what factors might lead to lymph node spread and recurrence in patients with early esophageal cancer who have had surgery, to help improve treatment decisions and avoid unnecessary treatments.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 15 Years to 85 Years
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06515964 on ClinicalTrials.gov

What this trial studies

This observational study aims to analyze risk factors for lymph node metastasis and recurrence in patients with early esophageal squamous cell carcinoma (ESCC) who have undergone endoscopic resection. It will utilize a multi-center collaborative research network and clinical big data to construct a large cohort of ESCC patients. The study will evaluate the discrimination efficiency of a newly established risk prediction model based on the collected data. By comparing retrospective and prospective data, the study seeks to refine treatment criteria and reduce overtreatment.

Who should consider this trial

Good fit: Ideal candidates include men and women aged 18-85 who have undergone endoscopic submucosal dissection for early ESCC and meet specific pathological criteria.

Not a fit: Patients who have received prior esophageal chemoradiotherapy or surgery, or those with incomplete pathological data, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate treatment guidelines and improved outcomes for patients with early esophageal cancer.

How similar studies have performed: While there is ongoing research in this area, this specific approach to constructing a risk prediction model for early ESCC after endoscopic resection is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Men and women, aged 18-85.
2. ESD was performed for early (superficial) esophageal squamous cell carcinoma, and the indication was in line with domestic and foreign guidelines.
3. The pathological stage after ESD was pT1a/pT1b.
4. The effective follow-up time after ESD was ≥3 years, or recurrence or LNM occurred during the follow-up period.

Exclusion Criteria:

1. Esophageal chemoradiotherapy or esophageal surgery were performed before ESD.
2. There is a history of carcinoma, early carcinoma, adenoma and other benign and malignant tumors of stomach and duodenum.
3. Pathological data after ESD were incomplete.
4. Combined with malignant tumors of other organs.
5. Fragmented endoscopic mucosal resection (EMR), multi-loop mucosal resection (MBM) and other endoscopic non-monolithic resection techniques were used.
6. New squamous cell carcinoma in other parts of esophagus during follow-up (metachronous carcinoma).

Where this trial is running

Shanghai, Shanghai Municipality

• Changhai Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Luowei Wang, Doctor

Conditions Early Esophageal Cancer