Endoscopic Screening on Esophageal Cancer

NCT02094105 | Completed DMC

• 1 other identifier: ESCC01
• Study Type: interventional
• Target: 45,386
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

esophageal cancer; screening; endoscopy; prevention

Outcome Measures

Primary Outcomes (1)

• incidence and mortality of ESCC

  10 years

Secondary Outcomes (1)

• Cumulative incidence and mortality of total cancer, and gastric cardia cancer

  10 years

Study Arms (2)

screening

EXPERIMENTAL

endoscopy examination with iodine staining

Procedure: Endoscopy examination with iodine staining

control

NO INTERVENTION

1/10 sampling questionnaire interview for control group.

Interventions

Endoscopy examination with iodine staining PROCEDURE

Endoscopy examination with Lugol's iodine staining and questionnaire once time and early treatment on precancerous lesions was undergone for the intervention group.

screening

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute/Hospital of Ci County

Handan, Hebei, 056500, China

Location

Related Publications (6)

• 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.

  PMID: 23861830 BACKGROUND

• 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.

  PMID: 23063415 BACKGROUND

• 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.

  PMID: 19672254 BACKGROUND

• 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.

  PMID: 1183721 BACKGROUND

• 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.

  PMID: 20654227 BACKGROUND

• 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.

  PMID: 22524212 BACKGROUND

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Youlin Qiao, PhD

  Department of Cancer Epidemiology, Cancer Institute, Chinese Academy of Medical Sciences, & Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Department of Cancer Epidemiology

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 21, 2014
• Study Start: November 1, 1999
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2013
• Last Updated: March 21, 2014

Record last verified: 2014-03

Locations

CN (1)