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

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ClinicalTrials.gov Identifier: NCT01688908
Recruitment Status : Active, not recruiting
First Posted : September 20, 2012
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Esophageal Squamous Cell Carcinoma Dysplasia Procedure: Endoscopy Screening

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33948 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Effcacy of Endoscopic Screening for Esophageal Cancer in China (ESECC): a Population-based Randomized Controlled Trial
Actual Study Start Date : January 1, 2012
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Esophageal cancer specific mortality [ Time Frame: 5-10 years ]
  2. Cost for saving 1 quality-adjusted life year (QALY) [ Time Frame: 5-10 years ]

Secondary Outcome Measures :
  1. Cumulative incidence of advanced esophageal cancer [ Time Frame: 5-10 years ]
  2. Change of life quality due to early diagnosis and treatment [ Time Frame: 5-10 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. permanent residency in one of the 668 target villages which were randomly selected from Hua County, Henan Province, 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. positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
  3. history of endoscopic examination within 5 years prior to the enrollment interview.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688908


Locations
China, Beijing
Laboratory of genetics, Peking University cancer Hospital and institute
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Peking University
Investigators
Principal Investigator: Yang Ke, M.D. Laboratory of genetics, Peking University cancer Hospital and institute
More Information

Additional Information:
Publications:
Responsible Party: Yang Ke, Professor, Peking University
ClinicalTrials.gov Identifier: NCT01688908     History of Changes
Other Study ID Numbers: 201202014
First Posted: September 20, 2012    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Keywords provided by Yang Ke, Peking University:
Esophageal Squamous Cell Carcinoma
Endoscopic Screening
Efficacy
Cost-utility
High risk region
China

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