China Early Esophageal Cancer Cohort

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

With the development of endoscopy, more and more patients with superficial esophageal squamous cell carcinoma (ESCC) receive endoscopic resection rather than traditional surgery. However, there is still no complete consensus on the risk factors for lymph node metastasis (LNM) and recurrence of ESCC after endoscopic resection. The existing curative resection criteria are strict to a certain extent, and a considerable number of patients are overtreated according to the current standard of additional treatment. Thus, we aim to conduct a multi-center retrospective and prospective study to construct a large cohort of ESCC based on the previously established multi-center collaborative research network and clinical big data, analyze the risk factors of LNM and recurrence in patients with early esophageal squamous cell carcinoma after ESD, establish an accurate and simple risk prediction model, and evaluate the discrimination efficiency of this model.

Study Overview

• Status: Recruiting
• Conditions: Early Esophageal Cancer
• Intervention / Treatment: Other: observational study

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Luowei Wang, Doctor; Phone Number: 13901833088; Email: wangluoweimd@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Changhai Hospital
      • Contact: Lei Xin, MD; Phone Number: 13817318134; Email: aip_xin@163.com
      • Principal Investigator: Luowei Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

From January 2015 to December 2020, no less than 1400 patients who received ESD treatment for early esophageal squamous cell carcinoma were expected to be included.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noncurative Resection	Noncurative resection was defined as the presence of residual tumor or lymph node metastasis at the vertical margin of the lesion confirmed by pathology after surgery, or local recurrence, lymph node metastasis, or distant metastasis attributable to the primary tumor during follow-up.	2022-12 Complete the preliminary clinical study preparation. 2023-10 Complete patient data analysis and sorting. 2024-10 Construct an accurate evaluation system. 2025-10 Conduct validation analysis of the evaluation system.

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; The Second Hospital of Hebei Medical University; West China Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Shandong Provincial Hospital; The First Affiliated Hospital of Soochow University; Henan Provincial People's Hospital; Zhongda Hospital; Sichuan Cancer Hospital and Research Institute; Affiliated Hospital of Southwest Medical University; Tongliao City Hospital; Shanxi Provincial People's Hospital; The Second Affiliated Hospital of Baotou Medical College; Yancheng First People's Hospital; Nanchong Central Hospital; Anyang Cancer Hospital; Jiangsu Province Hospital of Chinese Medicine; Lianshui People's Hospital; The second affiliated hospital of Xuzhou medical university; The second people's hospital of Nanyang

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: CEEC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No