Efficacy of Endoscopy Screening on Esophageal Cancer in China (ESECC) (ESECC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Peking University
Information provided by (Responsible Party):
Yang Ke, Peking University
ClinicalTrials.gov Identifier:
First received: September 17, 2012
Last updated: October 19, 2015
Last verified: October 2015
To evaluate the efficacy of endoscopy screening on esophageal cancer (EC) and determine the most cost-effective strategy of endoscopy screening in high risk population of 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 30,000 (~16,000 per group). Participants in the screening arm will accept standard endoscopy examination to detect early esophageal cancer and no screening were designed in control arm. The incidence of advanced EC and EC-specific mortality will be compared within the two groups to test the hypothesis that endoscopy screening would detect early stage cancer and the incidence of advanced stage EC and EC-specific mortality will be lower than control group. Cost-effectiveness analysis will also be conducted to find the most cost-effective strategy of endoscopy screening in rural China.

Condition Intervention
Esophageal Squamous Cell Carcinomas
Procedure: Endoscopy Screening

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Efficacy of Endoscopy Screening on Esophageal Cancer in a High Risk Region of Rural China: a Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Peking University:

Primary Outcome Measures:
  • Esophageal cancer specific mortality [ Time Frame: 5-10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cumulative incidence of advanced esophageal cancer [ Time Frame: 5-10 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Cost of saving 1 person-year of life [ Time Frame: 5-10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 32000
Study Start Date: January 2012
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Arm
Participants in this arm will not accept the endoscopy screening and only baseline and follow-up interview will be conducted in this arm.
Experimental: Screening Arm
Participants in this arm will accept a baseline endoscopy screening and questionnaire investigation and follow-up interview. If applicable, all participants in this arm will accept a second endoscopy screening in the 5th year of the study.
Procedure: Endoscopy Screening
  1. Upper G.I. endoscopy examination with Lugols Iodine in esophagus
  2. Biopsy at the visually abnormal sites
  3. Pathologic examination of all biopsy tissue specimens
  4. Advise of regular re-examination will be given to participants who are diagnosed of moderate and severe dysplasia.
  5. Advises of endoscopic or surgical treatment will be given to participants who are diagnosed of early upper G.I. carcinomas.

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Ages Eligible for Study:   45 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. permanent residency in one of the 668 target villages which were randomly selected from 846 villages of Hua County of Anyang, China;
  2. age between 45 and 69 years;
  3. willingness to participate in this study and complete all parts of the examination.

Exclusion Criteria:

  1. self-reported history of cancer, cardiovascular disease, mental disorder, or other contraindications for endoscopy;
  2. self-reported history of infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV), and any evidence of these infections based on serum screening;
  3. history of endoscopy examination within 5 years prior to the interview.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688908

Contact: Hong Cai, M.D. 8610-88196762 drhcai@gmail.com
Contact: Zhonghu He, Ph.D. 8610-88196762 zhonghuhe@gmail.com

Laboratory of Genetics, Beijing Cancer Hospital and Institute, Peking University Recruiting
Beijing, China, 100142
Contact: Hong Cai, M.D.    8610-88196762    drhcai@gmail.com   
Contact: Zhonghu He, Ph.D.    8610-88196762    zhonghuhe@gmail.com   
Principal Investigator: Hong Cai, M.D.         
Principal Investigator: Zhonghu He, Ph.D.         
Sponsors and Collaborators
Peking University
Principal Investigator: Yang Ke, M.D. Peking University
  More Information

Responsible Party: Yang Ke, Professor, Peking University
ClinicalTrials.gov Identifier: NCT01688908     History of Changes
Other Study ID Numbers: 201202014 
Study First Received: September 17, 2012
Last Updated: October 19, 2015
Health Authority: China: Ministry of Health

Keywords provided by Peking University:
Esophageal Squamous Cell carcinomas
Endoscopy Screening
High risk region

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on May 25, 2016