Esophageal Squamous Cell Carcinoma Clinical Trial
— ESECCOfficial title:
Effcacy of Endoscopic Screening for Esophageal Cancer in China (ESECC): a Population-based Randomized Controlled Trial
Verified date | January 2018 |
Source | Peking University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 33948 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 69 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Laboratory of genetics, Peking University cancer Hospital and institute | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University |
China,
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 control — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Esophageal cancer specific mortality | 5-10 years | ||
Primary | Cost for saving 1 quality-adjusted life year (QALY) | 5-10 years | ||
Secondary | Cumulative incidence of advanced esophageal cancer | 5-10 years | ||
Secondary | Change of life quality due to early diagnosis and treatment | 5-10 years |
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