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Clinical Trials/NCT02094105
NCT02094105
Completed
Not Applicable

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

Chinese Academy of Medical Sciences1 site in 1 country45,386 target enrollmentNovember 1999

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Squamous Cell Carcinoma
Sponsor
Chinese Academy of Medical Sciences
Enrollment
45386
Locations
1
Primary Endpoint
incidence and mortality of ESCC
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
November 1999
End Date
December 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Youlin Qiao

Professor and Director of Department of Cancer Epidemiology

Chinese Academy of Medical Sciences

Eligibility Criteria

Inclusion Criteria

  • local residents
  • Men and women aged 40 to 69 years
  • no contraindications for endoscopic examinations (e.g. history of reaction of iodine or lidocaine), and who were mentally and physically competent to provide written informed consent.
  • informed consent

Exclusion Criteria

  • Not local residents
  • age younger than 40 yrs and older than 69 yrs
  • History of reaction of iodine or lidocaine
  • contraindications for endoscopic examinations

Outcomes

Primary Outcomes

incidence and mortality of ESCC

Time Frame: 10 years

Secondary Outcomes

  • Cumulative incidence and mortality of total cancer, and gastric cardia cancer(10 years)

Study Sites (1)

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