Endoscopic Screening on Esophageal Cancer
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endoscopy examination with iodine staining
Sponsored by
About this trial
This is an interventional prevention trial for Esophageal Squamous Cell Carcinoma focused on measuring esophageal cancer, screening, endoscopy, prevention
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
Sites / Locations
- Cancer Institute/Hospital of Ci County
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
screening
control
Arm Description
endoscopy examination with iodine staining
1/10 sampling questionnaire interview for control group.
Outcomes
Primary Outcome Measures
incidence and mortality of ESCC
Secondary Outcome Measures
Cumulative incidence and mortality of total cancer, and gastric cardia cancer
Full Information
NCT ID
NCT02094105
First Posted
March 20, 2014
Last Updated
March 20, 2014
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02094105
Brief Title
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
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
esophageal cancer, screening, endoscopy, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45386 (Actual)
8. Arms, Groups, and Interventions
Arm Title
screening
Arm Type
Experimental
Arm Description
endoscopy examination with iodine staining
Arm Title
control
Arm Type
No Intervention
Arm Description
1/10 sampling questionnaire interview for control group.
Intervention Type
Procedure
Intervention Name(s)
Endoscopy examination with iodine staining
Intervention Description
Endoscopy examination with Lugol's iodine staining and questionnaire once time and early treatment on precancerous lesions was undergone for the intervention group.
Primary Outcome Measure Information:
Title
incidence and mortality of ESCC
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Cumulative incidence and mortality of total cancer, and gastric cardia cancer
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youlin Qiao, PhD
Organizational Affiliation
Department of Cancer Epidemiology, Cancer Institute, Chinese Academy of Medical Sciences, & Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute/Hospital of Ci County
City
Handan
State/Province
Hebei
ZIP/Postal Code
056500
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
23861830
Citation
Drahos J, Wu M, Anderson WF, Trivers KF, King J, Rosenberg PS, Eheman C, Cook MB. Regional variations in esophageal cancer rates by census region in the United States, 1999-2008. PLoS One. 2013 Jul 4;8(7):e67913. doi: 10.1371/journal.pone.0067913. Print 2013.
Results Reference
background
PubMed Identifier
23063415
Citation
Gonzalez L, Magno P, Ortiz AP, Ortiz-Ortiz K, Hess K, Nogueras-Gonzalez GM, Suarez E. Esophageal cancer incidence rates by histological type and overall: Puerto Rico versus the United States Surveillance, Epidemiology, and End Results population, 1992-2005. Cancer Epidemiol. 2013 Feb;37(1):5-10. doi: 10.1016/j.canep.2012.09.002. Epub 2012 Oct 11.
Results Reference
background
PubMed Identifier
19672254
Citation
Cook MB, Chow WH, Devesa SS. Oesophageal cancer incidence in the United States by race, sex, and histologic type, 1977-2005. Br J Cancer. 2009 Sep 1;101(5):855-9. doi: 10.1038/sj.bjc.6605246. Epub 2009 Aug 11.
Results Reference
background
PubMed Identifier
1183721
Citation
Cohen AM, Konigsberg IR. A clonal approach to the problem of neural crest determination. Dev Biol. 1975 Oct;46(2):262-80. doi: 10.1016/0012-1606(75)90104-9. No abstract available.
Results Reference
background
PubMed Identifier
20654227
Citation
Wei WQ, Yang J, Zhang SW, Chen WQ, Qiao YL. [Analysis of the esophageal cancer mortality in 2004 - 2005 and its trends during last 30 years in China]. Zhonghua Yu Fang Yi Xue Za Zhi. 2010 May;44(5):398-402. Chinese.
Results Reference
background
PubMed Identifier
22524212
Citation
Hiripi E, Jansen L, Gondos A, Emrich K, Holleczek B, Katalinic A, Luttmann S, Nennecke A, Brenner H; Gekid Cancer Survival Working Group. Survival of stomach and esophagus cancer patients in Germany in the early 21st century. Acta Oncol. 2012 Sep;51(7):906-14. doi: 10.3109/0284186X.2012.673732. Epub 2012 Apr 23.
Results Reference
background
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Endoscopic Screening on Esophageal Cancer
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