Endoscopic Screening on Esophageal Cancer

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094105
• Other study ID #: ESCC01
• Status: Completed
• Phase: N/A
• First received: March 20, 2014
• Last updated: March 20, 2014
• Start date: November 1999
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45386
• Est. completion date: December 2013
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 69 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	Cancer Institute/Hospital of Ci County	Handan	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (6)

Cohen AM, Konigsberg IR. A clonal approach to the problem of neural crest determination. Dev Biol. 1975 Oct;46(2):262-80. — View 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. — View 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. — View Citation

González L, Magno P, Ortiz AP, Ortiz-Ortiz K, Hess K, Nogueras-González GM, Suárez 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. — View 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. Epub 2012 Apr 23. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence and mortality of ESCC		10 years	No
Secondary	Cumulative incidence and mortality of total cancer, and gastric cardia cancer		10 years	No