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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
Sponsor:
Information provided by (Responsible Party):
Youlin Qiao, Chinese Academy of Medical Sciences

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


Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Procedure: Endoscopy examination with iodine staining Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45386 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine

Arm Intervention/treatment
Experimental: screening
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.



Primary Outcome Measures :
  1. incidence and mortality of ESCC [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Cumulative incidence and mortality of total cancer, and gastric cardia cancer [ Time Frame: 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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China, Hebei
Cancer Institute/Hospital of Ci County
Handan, Hebei, China, 056500
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Youlin Qiao, PhD Department of Cancer Epidemiology, Cancer Institute, Chinese Academy of Medical Sciences, & Peking Union Medical College

Publications:
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Responsible Party: Youlin Qiao, Professor and Director of Department of Cancer Epidemiology, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02094105     History of Changes
Other Study ID Numbers: ESCC01
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: March 21, 2014
Last Verified: March 2014
Keywords provided by Youlin Qiao, Chinese Academy of Medical Sciences:
esophageal cancer
screening
endoscopy
prevention
Additional relevant MeSH terms:
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Esophageal Neoplasms
Esophageal Squamous Cell Carcinoma
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
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs