Endoscopic Screening on Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT02094105|
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : March 21, 2014
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
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Squamous Cell Carcinoma||Procedure: Endoscopy examination with iodine staining||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45386 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 1999|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2013|
endoscopy examination with iodine staining
Procedure: Endoscopy examination with iodine staining
Endoscopy examination with Lugol's iodine staining and questionnaire once time and early treatment on precancerous lesions was undergone for the intervention group.
No Intervention: control
1/10 sampling questionnaire interview for control group.
- incidence and mortality of ESCC [ Time Frame: 10 years ]
- Cumulative incidence and mortality of total cancer, and gastric cardia cancer [ Time Frame: 10 years ]
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): NCT02094105
|Cancer Institute/Hospital of Ci County|
|Handan, Hebei, China, 056500|
|Principal Investigator:||Youlin Qiao, PhD||Department of Cancer Epidemiology, Cancer Institute, Chinese Academy of Medical Sciences, & Peking Union Medical College|