Clinical trial · Observational
Esophageal cAncer Screening Trial
Esophageal cAncer Screening Trial (EAST) Based on Novel Sponge Cytology：a Multicenter Nationwide Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sponge cytological test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Screening population
- description
- 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.
- interventionNames
- Diagnostic Test: Sponge cytological test
Primary outcomes (1)
- measure
- Diagnostic performance of the sponge cytology-based machine learning model for the main target lesions
- timeFrame
- through study completion, an average of 1.5 year
- description
- 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.
Secondary outcomes (3)
- measure
- Diagnostic performance of cytologist under AI assistance
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * subjects underwent opportunistic endoscopic screening for esophageal cancer; * aged 40-75 years. Exclusion Criteria: * 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.
References
Publications (3)
- BACKGROUNDGao 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
- DERIVEDBian 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. 2026 Jul 1;121(7):1600-1608. doi: 10.14309/ajg.0000000000003745. Epub 2025 Aug 22. PMID 40844617
- DERIVEDHuang 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