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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 23, 2018
Sponsor:
Information provided by (Responsible Party):
Yang Ke, Peking University

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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Dysplasia Procedure: Endoscopic Screening Not Applicable

  Show Detailed Description

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

Arm Intervention/treatment
No Intervention: Control Arm
Participants in this arm will not accept the endoscopic 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 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
  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.



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 ]


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
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.

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

Additional Information:
Publications of Results:
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 23, 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