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CompletedNCT02094105Updated Mar 21, 2014

Endoscopic Screening on Esophageal Cancer

An interventional study of Endoscopy examination with iodine staining in Esophageal Squamous Cell Carcinoma, sponsored by Chinese Academy of Medical Sciences. Completed at 1 site in China. Open to participants aged 40 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-21.

Sponsored by Chinese Academy of Medical Sciences · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
45,386
Allocation
Non-randomized
Ages
40 Years to 69 Years
Sex
All
01

Study 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

02

Conditions studied

  • Esophageal Squamous Cell Carcinoma

Keywords

  • esophageal cancer
  • screening
  • endoscopy
  • prevention
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In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 460 are open to participants now.

This study's enrollment of 45,386 is above the median of 58 across 1,170 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45,386 participants (actual)

Study arms

  • Experimental
    screening

    endoscopy examination with iodine staining

    Procedure: Endoscopy examination with iodine staining

  • No intervention
    control

    1/10 sampling questionnaire interview for control group.

Interventions

  • ProcedureEndoscopy 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.

06

What researchers measure

Primary outcomes

  1. incidence and mortality of ESCC

    Time frame: 10 years

Secondary outcomes

  1. Cumulative incidence and mortality of total cancer, and gastric cardia cancer

    Time frame: 10 years

07

Study locations

1 site
  • Cancer Institute/Hospital of Ci County
    Handan, Hebei 056500, China
08

References and documents

Publications

  • 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. PubMed 23861830 ↗
  • 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. PubMed 23063415 ↗
  • 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. PubMed 19672254 ↗
  • 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. PubMed 1183721 ↗
  • 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. PubMed 20654227 ↗
  • 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. PubMed 22524212 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02094105
Lead sponsor
Chinese Academy of Medical Sciences
Responsible party
Youlin Qiao (Professor and Director of Department of Cancer Epidemiology, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Mar 21, 2014
Start date
Nov 1999
Primary completion
Dec 2009
Completion
Dec 2013
Last update
Mar 21, 2014

Study contacts

Youlin Qiao, PhD
principal investigator · Department of Cancer Epidemiology, Cancer Institute, Chinese Academy of Medical Sciences, & Peking Union Medical College

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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