Clinical trial NCT02094105: Endoscopic Screening on Esophageal Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: esophageal cancer
screening
endoscopy
prevention
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2014-03-21
Enrollment: 45386
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: incidence and mortality of ESCC
timeFrame: 10 years
Secondary outcomes:
measure: Cumulative incidence and mortality of total cancer, and gastric cardia cancer
timeFrame: 10 years
Other outcomes:
Locations:
city: Handan
country: China
facility: Cancer Institute/Hospital of Ci County
state: Hebei
Study officials:
affiliation: Department of Cancer Epidemiology, Cancer Institute, Chinese Academy of Medical Sciences, & Peking Union Medical College
name: Youlin Qiao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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