NCT01688908

Brief Summary

To evaluate the efficacy of endoscopic screening on esophageal cancer (EC) and determine the most cost-effective strategy of endoscopic screening in high risk population in China, 668 villages of Hua county, a high risk area of esophageal cancer, were randomized into screening arm and control arm in a ratio of 1:1 and the total sample size is over 32,000 (\~16,000 per group). Participants in the screening arm will accept standard chromoendoscopy examination to detect early esophageal cancer and no screening were designed in the control arm. The incidence of advanced EC, EC-specific mortality and all-cause mortality will be compared within the two groups to test the hypothesis that endoscopic screening would alter the natural history of lesions in esophagus and the incidence of advanced stage EC, EC-specific mortality and all-cause mortality in the screening arm will be lower than the control group. Cost-effectiveness analysis will also be conducted to find the most cost-effective strategy of endoscopic screening in rural China.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33,948

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jan 2012Dec 2027

Study Start

First participant enrolled

January 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2012

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

11 years

First QC Date

September 17, 2012

Last Update Submit

January 18, 2018

Conditions

Esophageal Squamous Cell CarcinomaDysplasia

Keywords

Esophageal Squamous Cell CarcinomaEndoscopic ScreeningEfficacyCost-utilityHigh risk regionChina

Outcome Measures

Primary Outcomes (2)

  • Esophageal cancer specific mortality

    5-10 years

  • Cost for saving 1 quality-adjusted life year (QALY)

    5-10 years

Secondary Outcomes (2)

  • Cumulative incidence of advanced esophageal cancer

    5-10 years

  • Change of life quality due to early diagnosis and treatment

    5-10 years

Study Arms (2)

Control Arm

NO INTERVENTION

Participants in this arm will not accept the endoscopic screening and only baseline and follow-up interview will be conducted in this arm.

Screening Arm

EXPERIMENTAL

Participants in this arm will accept a baseline endoscopic screening, questionnaire investigation and follow-up interview. Subsequent re-examination and further medical services would be arranged among individuals who already have high-grade lesions found at baseline screening.

Procedure: Endoscopic Screening

Interventions

Endoscopic ScreeningPROCEDURE

1. Upper G.I. endoscopic examination with Lugols Iodine in esophagus 2. Biopsy at the visually abnormal sites 3. Pathologic examination of all biopsy tissue specimens 4. Subsequent re-examination and further medical services among individuals who already have high-grade lesions found at screening. 5. Advises of endoscopic or surgical treatment will be given to participants who are diagnosed of high grade upper G.I. lesions.

Screening Arm

Eligibility Criteria

Age45 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Participants were eligible for the study if they meet the following criteria: 1) permanent residency in a target village; 2) age 45-69 (\>5 years of life expectancy), and no history of endoscopic examination within 5 years prior to the initial interview; 3) no history of cancer or mental disorder; 4) negative for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV); 5) voluntary participation and agreement to complete all phases of the examination.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Laboratory of genetics, Peking University cancer Hospital and institute

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (11)

  • He Z, Liu Z, Liu M, Guo C, Xu R, Li F, Liu A, Yang H, Shen L, Wu Q, Duan L, Li X, Zhang C, Pan Y, Cai H, Ke Y. Efficacy of endoscopic screening for esophageal cancer in China (ESECC): design and preliminary results of a population-based randomised controlled trial. Gut. 2019 Feb;68(2):198-206. doi: 10.1136/gutjnl-2017-315520. Epub 2018 Jan 6.

    PMID: 29306867RESULT

  • He Z, Ke Y. Evolving diagnostic and surveillance strategies in esophageal cancer screening: Evidence from population-based studies in China. Chin J Cancer Res. 2025 Dec 30;37(6):929-936. doi: 10.21147/j.issn.1000-9604.2025.06.05.

    PMID: 41523838DERIVED

  • Wu M, Tian H, Guo C, Liu Z, Pan Y, Liu F, Liu Y, Yang W, Chen H, Hu Z, Liu M, He Z, Ke Y. Early-life undernutrition increases the risk of death from chronic diseases in adulthood: a population-based cohort study. Glob Health Res Policy. 2025 Jul 10;10(1):28. doi: 10.1186/s41256-025-00422-0.

    PMID: 40635115DERIVED

  • Liu M, Yang W, Guo C, Liu Z, Li F, Liu A, Yang H, Shen L, Wu Q, Duan L, Wang H, Tian H, Shi C, Pan Y, Liu Y, Liu F, Weiss NS, Cai H, He Z, Ke Y. Effectiveness of Endoscopic Screening on Esophageal Cancer Incidence and Mortality: A 9-Year Report of the Endoscopic Screening for Esophageal Cancer in China (ESECC) Randomized Trial. J Clin Oncol. 2024 May 10;42(14):1655-1664. doi: 10.1200/JCO.23.01284. Epub 2024 Mar 8.

    PMID: 38457759DERIVED

  • Zheng H, Liu Z, Chen Y, Ji P, Fang Z, He Y, Guo C, Xiao P, Wang C, Yin W, Li F, Chen X, Liu M, Pan Y, Liu F, Liu Y, He Z, Ke Y. Development and external validation of a quantitative diagnostic model for malignant gastric lesions in clinical opportunistic screening: A multicenter real-world study. Chin Med J (Engl). 2024 Oct 5;137(19):2343-2350. doi: 10.1097/CM9.0000000000002903. Epub 2024 Feb 26.

    PMID: 38403900DERIVED

  • Liu M, Qi Z, Zhou R, Guo C, Liu A, Yang H, Li F, Duan L, Shen L, Wu Q, Liu Z, Pan Y, Liu F, Liu Y, Cai H, He Z, Ke Y. How should extra-large Lugol-unstained lesions of the esophagus be treated? Results from a population-based cohort study. Cancer Med. 2023 Oct;12(19):20129-20139. doi: 10.1002/cam4.6592. Epub 2023 Sep 21.

    PMID: 37732496DERIVED

  • Liu Z, Liu M, Liu Y, Zhou R, Abliz A, Yuan W, Guo C, Zhang L, He W, Zheng H, Huang Y, Pan Y, Liu F, Hu Z, Chen H, Cai H, He Z, Ke Y. Absence of Lugol staining indicates initiation of esophageal squamous cell carcinoma: A combined genomic and epidemiologic study. Cell Rep Med. 2023 Sep 19;4(9):101168. doi: 10.1016/j.xcrm.2023.101168. Epub 2023 Aug 24.

    PMID: 37625408DERIVED

  • Hu N, Wang K, Zhang L, Liu ZJ, Jin Z, Cui RL, Zhang HJ, He ZH, Ke Y, Duan LP. Epidemiological and clinical features of functional dyspepsia in a region with a high incidence of esophageal cancer in China. Chin Med J (Engl). 2021 Jun 4;134(12):1422-1430. doi: 10.1097/CM9.0000000000001584.

    PMID: 34091519DERIVED

  • Wang MM, Guo CH, Li FL, Xu RP, Liu Z, Pan YQ, Liu FF, Liu Y, Cai H, Liu MF, He ZH, Ke Y. Family history of esophageal cancer modifies the association of serum lipids and malignant esophageal lesions: a nested case-control study from the "Endoscopic Screening for Esophageal Cancer in China" trial. Chin Med J (Engl). 2021 Apr 7;134(9):1079-1086. doi: 10.1097/CM9.0000000000001432.

    PMID: 33840743DERIVED

  • Li F, Li X, Guo C, Xu R, Li F, Pan Y, Liu M, Liu Z, Shi C, Wang H, Wang M, Tian H, Liu F, Liu Y, Li J, Cai H, Yang L, He Z, Ke Y. Estimation of Cost for Endoscopic Screening for Esophageal Cancer in a High-Risk Population in Rural China: Results from a Population-Level Randomized Controlled Trial. Pharmacoeconomics. 2019 Jun;37(6):819-827. doi: 10.1007/s40273-019-00766-9.

    PMID: 30809788DERIVED

  • Wang H, Pan Y, Guo C, Li F, Xu R, Liu M, Liu Z, Liu F, Cai H, Ke Y, He Z. Health-related quality of life among rural residents aged 45-69 years in Hua County, Henan Province, China: Results of ESECC Trial for esophageal cancer screening with endoscopy. Chin J Cancer Res. 2018 Apr;30(2):240-253. doi: 10.21147/j.issn.1000-9604.2018.02.07.

    PMID: 29861609DERIVED

Related Links

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Yang Ke, M.D.

    Laboratory of genetics, Peking University cancer Hospital and institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 20, 2012

Study Start

January 1, 2012

Primary Completion

December 31, 2022

Study Completion (Estimated)

December 31, 2027

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

CN(1)