Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
Effect of Endoscopic Screening on Esophageal Cancer Incidence and Mortality: 10-year Follow up of a Community-based, Controlled Study Among High Risk Population in China
Importance: There are no global screening recommendations for esophageal squamous cell
carcinoma (ESCC). Endoscopic screening has been investigated in high incidence areas of
China since 1970's. But up until now there no apparent evidence that would lead to a
reduction in disease morbidity and mortality.
Objective: To evaluate whether endoscopic screening and early intervention program could
reduce the incidence or mortality of ESCC.
Design: Community-based, controlled cohort study among 45 386 residents, Endoscopy screening
was completed from November 1999 to May of 2000. Subjects in intervention group were
examined once during intervention period. The study follow-up concluded in December 2009.
Setting: High risk area of ESCC in China
Participants:Cluster sampling from communities with high rates of esophageal cancer. A set
of villages with was selected as the study intervention community. Age 40 to 69 years
residents were selected as an eligible population. Another set of villages was select as the
control population. Buffer villages were set up between intervention and control group.
Intervention: Endoscopy with Lugol's iodine staining and early treatment on precancerous
lesions was undergone for the intervention group.
Main Outcome(s) and Measure(s): Incidence and mortality ESCC
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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