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Efficacy of Endoscopy Screening on Esophageal Cancer in China (ESECC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Peking University
Sponsor:
Information provided by (Responsible Party):
Yang Ke, Peking University
ClinicalTrials.gov Identifier:
NCT01688908
First received: September 17, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

The purposes of this study are as follows:

  1. Establish clinical criteria of endoscopy screening on esophageal cancer in high risk region of China;
  2. Evaluate the efficacy of endoscopy screening on esophageal cancer;
  3. Determine the most cost-effective strategy of endoscopy screening in high risk population of China.

Condition Intervention
Esophageal Squamous Cell Carcinomas
Procedure: Endoscopy Screening

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Efficacy of Endoscopy Screening on Esophageal Cancer in a High Risk Region of Rural China: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • Esophageal cancer specific mortality [ Time Frame: 5-10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cumulative incidence of advanced esophageal cancer [ Time Frame: 5-10 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Cost of saving 1 person-year of life [ Time Frame: 5-10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 32000
Study Start Date: January 2012
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Arm
Participants in this arm will not accept the endoscopy screening. And only baseline and follow-up interview and an alternative abdominal ultrasound scan will be conducted in this arm.
Experimental: Screening Arm
Participants in this arm will accept a baseline endoscopy screening and questionnaire investigation and follow-up interview. If applicable, all participants in this arm will accept a second endoscopy screening in the 5th year of the study.
Procedure: Endoscopy Screening
  1. Upper G.I. endoscopy examination with Lugols Iodine in esophagus
  2. Biopsy at the visually abnormal sites
  3. Pathologic examination of all biopsy tissue specimens
  4. Advise of regular re-examination will be given to participants who are diagnosed of moderate and severe dysplasia.
  5. Advises of endoscopic or surgical treatment will be given to participants who are diagnosed of early upper G.I. carcinomas.

  Eligibility

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. permanent residency in one of the 334 target villages which were randomly selected from all the 968 villages of Hua County of Anyang, China;
  2. age between 40 and 69 years;
  3. willingness to participate in this study and complete all parts of the examination.

Exclusion Criteria:

  1. self-reported history of cancer, cardiovascular disease, mental disorder, or other contraindications for endoscopy;
  2. self-reported history of infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV), and any evidence of these infections based on serum screening;
  3. history of endoscopy examination within 5 years prior to the interview.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688908

Contacts
Contact: Hong Cai, M.D. 8610-88196762 drhcai@gmail.com
Contact: Zhonghu He, Ph.D. 8610-88196762 zhonghuhe@gmail.com

Locations
China, Bejing
Laboratory of Genetics, Beijing Cancer Hospital and Institute, Peking University Recruiting
Beijing, Bejing, China, 100142
Contact: Hong Cai, M.D.    8610-88196762    drhcai@gmail.com   
Contact: Zhonghu He, Ph.D.    8610-88196762    zhonghuhe@gmail.com   
Sub-Investigator: Hong Cai, M.D.         
Sponsors and Collaborators
Peking University
Investigators
Principal Investigator: Yang Ke, M.D. Peking University
  More Information

No publications provided

Responsible Party: Yang Ke, Professor, Peking University
ClinicalTrials.gov Identifier: NCT01688908     History of Changes
Other Study ID Numbers: 201202014
Study First Received: September 17, 2012
Last Updated: September 17, 2012
Health Authority: China: Ministry of Health

Keywords provided by Peking University:
Esophageal Squamous Cell carcinomas
Endoscopy Screening
High risk region
China

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on November 27, 2014