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OpenTrials
Completed

NCT Number: NCT02094105

Endoscopic Screening on Esophageal Cancer

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

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Key information

Conditions

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

Age range

40 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Institute/Hospital of Ci County

Handan, Hebei, 056500, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
1999
Primary completion
2009
Study completion
2013
First posted
Mar 21, 2014
Registry last updated
Mar 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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