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Esophageal cAncer Screening Trial

NCT04609813 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14597

Last updated 2022-09-21

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Sponge cytological 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.

Sponsors & Collaborators

  • Shanghai Municipal Science and Technology Commission

    collaborator OTHER_GOV

  • Changhai Hospital

    lead OTHER

Principal Investigators

  • Zhao-Shen Li, MD · Changhai Hospital

  • Luo-Wei Wang, MD · Changhai Hospital

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04609813 on ClinicalTrials.gov