Esophageal cAncer Screening Trial

NCT04609813 | Completed DMC

• 1 other identifier: EAST
• Study Type: observational
• Target: 14,597
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter study aims to include 15000 participants undergoing screening upper gastrointestinal endoscopy and establish a risk prediction model for esophageal squamous cell carcinoma and esophagogastric junctional (EGJ) adenocarcinoma in high-risk areas. The prediction model will be built based on epidemiological and cytological features, acquired from the esophageal sponge cytology test. The primary study outcome is the diagnostic performance of the model to detect high-grade lesions (including carcinoma and high-grade intraepithelial neoplasia) of the esophagus and EGJ. Secondary outcomes include the number needed to screen, and dignostic performance of cytologist under AI assistance and abnornal cell count.

Conditions

Esophageal Squamous Cell Carcinoma; Esophageal Cancer; Gastroesophageal Junction Adenocarcinoma

Keywords

Esophageal Cancer; Screening and Early Detection; Sponge Cytology; Risk Stratification

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of the sponge cytology-based machine learning model for the main target lesions

  The main target lesions include high-grade intraepithelial neoplasia and carcinoma of the esophagus and gastroesophageal junction. Diagnostic performance include AUC, average precision, sensitivity, specificity, positive predictive value, and negative predictive value.

  through study completion, an average of 1.5 year

Secondary Outcomes (3)

• Diagnostic performance of cytologist under AI assistance

  through study completion, an average of 1.5 year

• Numbers needed to screen

  through study completion, an average of 1.5 year

• Diagnostic performance of abnormal cell count

  through study completion, an average of 1.5 year

Study Arms (1)

Screening population

Participants underwent opportunistic endoscopic screening for esophageal cancer in high-risk regions in China will be enrolled in this study. Esophageal cell specimen will be collected by esophageal sponge cell collection device (Esoheal 1.0) prior to endoscopic examinations.

Diagnostic Test: Sponge cytological test

Interventions

Sponge cytological test DIAGNOSTIC_TEST

Esophageal cell specimen were collected with Esoheal 1.0 sponge collection device. A prediction model will be built based on digital cytopathological features of participants.

Screening population

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study enrolled participants undergoing endoscopic opportunistic screening for esophageal cancer, after excluding participants with alarming symptoms, known history of esophageal neoplasia, previous upper endoscopy within one year, and conditions that are not suitable for endoscopy and biopsy.

You may qualify if:

• subjects underwent opportunistic endoscopic screening for esophageal cancer;
• aged 40-75 years.

You may not qualify if:

• subjects with alarming symptoms including dysphagia, hematemesis, and melena;
• subjects underwent upper endoscopy within 1 year;
• subjects with history of esophageal neoplasia;
• subjects with esophageal-gastric varices or esophageal stenosis;
• subjects with histories of esophageal or gastric surgery;
• subjects with coagulation disorders or taking anticoagulant or antiplatelet agents;
• subjects with other contraindications for upper endoscopy or biopsy;
• subjects with other serious disease or malignant tumor, and the life expectancy is less than 5 years;
• subjects that refuse to cooperate with data collection or sign the informed consent.

Sponsors & Collaborators

• Changhai Hospital: lead
• Shanghai Municipal Science and Technology Commission: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (3)

• Gao Y, Xin L, Feng YD, Yao B, Lin H, Sun C, An W, Li ZS, Shi RH, Wang LW. Feasibility and Accuracy of Artificial Intelligence-Assisted Sponge Cytology for Community-Based Esophageal Squamous Cell Carcinoma Screening in China. Am J Gastroenterol. 2021 Nov 1;116(11):2207-2215. doi: 10.14309/ajg.0000000000001499.

  PMID: 34546186 BACKGROUND

• Bian Y, Xu Y, Chu C, Gao Y, Jiang H, Meng Q, Yu C, Zhou J, Li Z, Wang W, Lin H, Wang L. Accurate Nonendoscopic Detection of Early Esophageal Squamous Malignant Lesions Using Sponge-Based Methylated DNA Biomarkers. Am J Gastroenterol. 2025 Aug 22. doi: 10.14309/ajg.0000000000003745. Online ahead of print.

  PMID: 40844617 DERIVED

• Huang S, Gu X, Zhou H, Feng Y, Shi R, Wang W, Zhou A, Lin J. Application of Esophageal Sponge Cytology in Screening Esophageal Squamous Cell Carcinoma in a High-Risk Region of China. Cancer Med. 2025 Feb;14(3):e70467. doi: 10.1002/cam4.70467.

  PMID: 39856802 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

1. Esophageal cell specimen collected with novel sponge cell collection device; 2. Esophageal formalin-fixed paraffin-embedding tissue sample collected with endoscopic biopsy.

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Zhao-Shen Li, MD

  Changhai Hospital

  STUDY DIRECTOR

• Luo-Wei Wang, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: January 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)