Esophageal cAncer Screening Trial (EAST)

September 17, 2022 updated by: Zhaoshen Li, Changhai Hospital

Esophageal cAncer Screening Trial (EAST) Based on Novel Sponge Cytology：a Multicenter Nationwide Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Esophageal cancer is the seventh most common cancer and the sixth leading cause of cancer related death worldwide in 2020. The highest-incidence areas include Eastern and Central Asia, sub-Saharan Africa, and some South American countries, with esophageal squamous cell carcinoma (ESCC) being the dominant histologic subtype (nearly 90%). While esophageal adenocarcinoma, as a type of adenocarcinoma of the esophagogastric junction (AEG), was less common in these high-risk areas, but accounts for approximately two-thirds of esophageal cancer cases in Europe and North America. However, cardiac gastric cancer, another type of AEG, often shows high incidence in ESCC high-risk areas. Strikingly, 57.5% of global ESCC cases and 60.8% of cardiac gastric cancer cases were estimated to occur in China in 2018. Most esophageal cancer high-risk areas locate in developing countries with limited medical resources, high incidence and co-occurrence ESCC and AEG have posed significant challenges for disease control.

Both ESCC and AEG demonstrate dismal prognosis, with an overall 5-year survival of less than 30%. This is largely due to the asymptomatic nature of early-stage lesions, which frequently leads to delayed diagnosis. Population-based studies in China have confirmed that upper gastrointestinal endoscopy with Lugol's staining could increase the early detection rate and decrease both the incidence and mortality of ESCC and the mortality of AEG in very high-risk areas. However, the invasiveness and resource intensiveness of endoscopic procedure and relative low prevalence of target lesions in the general screening population (0.8% to 1.6%) limit its feasibility and cost-effectiveness in massive screening. Therefore, developing less invasive, readily accessible methods with acceptable diagnostic accuracy is urgently needed for enrichment of high-risk individuals prior to endoscopy. To date, few non-endoscopic preliminary screening methods were available for ESCC and AEG.

The esophageal sponge cytology is an emerging, minimally invasive, and convenient test for esophageal cancer as well as its precancerous lesions and conditions. The expandable sponge could harvest epithelial cells from the entire esophagus and the esophagogastric junction (EGJ) during withdrawn, and subsequent morphological or biomarker analysis could be performed. For Barrett esophagus (BE), the Cytosponge-trefoil factor 3 is a well-established non-endoscopic test, and could increase the detection of BE for 10.6-fold among patients with reflux symptoms in the primary care setting. For high-risk areas, where ESCC is the dominant subtype, several types of sponge cytology tests also gained promising yet preliminary results.

In our previous study, we have developed an artificial intelligence (AI)-assisted sponge cytology test, which automatically indicated potentially abnormal cells for cytologist diagnosis, and found the sensitivity and specificity to be 90.0% and 93.7% in community-based ESCC screening in China. However, the inadequacy of experienced cytologists makes this method still suboptimal for population-based screening, especially for resource-limited areas. Furthermore, AEG, which is also within the detection range of the sponge cytology, has not been investigated in previous studies. Therefore, we conducted the Esophageal cAncer Screening Trial (EAST) to develop and validate a fully-automated machine learning model based on cytological and epidemiological features for ESCC and AEG screening in high-risk areas.

Study Type

Observational

Enrollment (Actual)

14597

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of the sponge cytology-based machine learning model for the main target lesions
Time Frame: through study completion, an average of 1.5 year

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of cytologist under AI assistance
Time Frame: through study completion, an average of 1.5 year

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
Numbers needed to screen
Time Frame: through study completion, an average of 1.5 year
Numbers of participants needed to screen to prevent one main target lesion.
through study completion, an average of 1.5 year
Diagnostic performance of abnormal cell count
Time Frame: through study completion, an average of 1.5 year

The main target lesions include high-grade intraepithelial neoplasia and carcinoma of the esophagus and gastroesophageal junction.

Diagnostic performance include AUC and average precision.
through study completion, an average of 1.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

Shanghai Municipal Science and Technology Commission

Investigators

  • Study Director: Zhao-Shen Li, MD, Changhai Hospital
  • Principal Investigator: Luo-Wei Wang, MD, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

October 29, 2020

First Posted (Actual)

October 30, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 17, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD will not be made available to the public, but could be provided by the investigator on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Cancer

Clinical Trials on Sponge cytological test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe