EAST: Esophageal cAncer Screening Trial

Sponsor

Changhai Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04609813

Collaborator

(none)

14,597

Enrollment

Location

17.9

Actual Duration (Months)

815.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This multicenter study aims to include 15000 upper gastrointestinal endoscopy and establish a risk prediction model for esophageal cancer. This study will propose a table, including Risk factors for esophageal cancer and evaluate the function and value of new type esophageal cell collector to China's esophageal cancer screening. The primary study outcome is the sensitivity and specificity of the model to diagnose esophageal cancer. Secondary outcomes include sensitivity and specificity of the esophageal cytology to diagnose esophageal cancer.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma Esophageal Cancer Gastroesophageal Junction Adenocarcinoma	Diagnostic Test: Sponge cytological test

Detailed Description

Esophageal cancer is one of the most unknown and deadiest cancers worldwide, mainly because of its extremely aggressive nature and poor survival rate. In 2018, the incidence rate and mortality rate of esophageal cancer were 6.3/100000 and 5.5/100000. There are clear differences between the risk factors of both histological types that affect their incidence and distribution worldwide.There are areas of high incidence of squamous cell carcinoma (some areas in China) that meet the requirements for cost-effectiveness of endoscopy for early diagnosis in the general population of those areas. The gold standard to detect and diagnose esophageal cancer is upper gastrointestinal endoscopy with biopsy. However, China is a country with large population, which makes it difficult to perform screening endoscopy in the whole crowd. There are several researches showing that there is a low detecting rate of esophageal cancer if only perform screening endoscopy in high risk area. This multicenter study aims to propose a table, including Risk factors for esophageal cancer.

Besides, esophageal cytology is essential to detect and diagnose esophageal. Now there are improved esophageal cell collector（CytospongeTM、EsophaCapTM）which adopt an inflatable sponge capsule design to increase the contact area with the esophageal mucosa. Our study aims to evaluate the function and value of new type esophageal cell collector to China's esophageal cancer screening.

Study Design

Study Type:

Observational

Actual Enrollment :

14597 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Jun 30, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Opportunistic 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.

Arm

Intervention/Treatment

Opportunistic 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.

Outcome Measures

Primary Outcome Measures

Diagnostic performance of the sponge cytology-based prediction model for the main target lesions [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, accuracy, sensitivity, specificity, positive predictive value, and negative predictive value.

Secondary Outcome Measures

Diagnostic performance of AI-assisted cytology [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, accuracy, sensitivity, specificity, positive predictive value, and negative predictive value.
Numbers needed to screen [through study completion, an average of 1.5 year]
Numbers of participants needed to screen to prevent one main target lesion.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.