Esophageal Squamous Cell CarcinomaEASTNCT04609813
Esophageal cAncer Screening Trial
An observational study of Esophageal Squamous Cell Carcinoma and Esophageal Cancer, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Esophageal Cancer, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Sponge cytological test
- How many people
- 14,597 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- subjects underwent opportunistic endoscopic screening for esophageal cancer;
- aged 40-75 years.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophageal Squamous Cell Carcinoma, Esophageal Cancer, Gastroesophageal Junction Adenocarcinoma
- Being tested
- Sponge cytological test
- Keywords
- Esophageal Cancer, Screening and Early Detection, Sponge Cytology, Risk Stratification
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sponge cytological testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Sponge cytological test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1.5 year
Secondary outcomes (3)
Diagnostic performance of cytologist under AI assistance
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.
Measured: through study completion, an average of 1.5 year
Numbers needed to screen
Numbers of participants needed to screen to prevent one main target lesion.
Measured: through study completion, an average of 1.5 year
Diagnostic performance of abnormal cell count
The main target lesions include high-grade intraepithelial neoplasia and carcinoma of the esophagus and gastroesophageal junction.
Diagnostic performance include AUC and average precision.
Measured: through study completion, an average of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 Jan 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 14,597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhao-Shen Li, MD, Study director, Changhai HospitalLuo-Wei Wang, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609813
- Sponsor's protocol ID
- EAST
- Acronym
- EAST
- Status last verified
- Sep 2022
- First submitted
- 26 Oct 2020
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be made available to the public, but could be provided by the investigator on reasonable request.
Publications
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.
PubMed 34546186Bian 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.
PubMed 40844617Huang 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.
PubMed 39856802
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal cAncer Screening Trial (EAST) Based on Novel Sponge Cytology：a Multicenter Nationwide Study
- ClinicalTrials.gov ID
- NCT04609813
- Acronym / sponsor ID
- EAST / EAST
- Conditions
- Esophageal Squamous Cell Carcinoma, Esophageal Cancer, Gastroesophageal Junction Adenocarcinoma
- Keywords
- Esophageal Cancer, Screening and Early Detection, Sponge Cytology, Risk Stratification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,597 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening population | – | Diagnostic Test: Sponge cytological testParticipants 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- subjects underwent opportunistic endoscopic screening for esophageal cancer;
- aged 40-75 years.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sponge cytological testEsophageal cell specimen were collected with Esoheal 1.0 sponge collection device. A prediction model will be built based on digital cytopathological features of participants. | Diagnostic test | Screening population |
Primary outcome
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.
3 secondary outcomes
Diagnostic performance of cytologist under AI assistance
Time frame: through study completion, an average of 1.5 year
Numbers needed to screen
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Background: PubMed 34546186Gao 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.
- Derived from this study: PubMed 40844617Bian 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.
- Derived from this study: PubMed 39856802Huang 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.
- Individual participant dataSharing planned: No. The IPD will not be made available to the public, but could be provided by the investigator on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhao-Shen Li, MD study director
Changhai Hospital
Luo-Wei Wang, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma and Esophageal Cancer, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04609813, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.