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

NCT01688908 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33948

Last updated 2018-01-23

No results posted yet for this study

Summary

To evaluate the efficacy of endoscopic screening on esophageal cancer (EC) and determine the most cost-effective strategy of endoscopic screening in high risk population in China, 668 villages of Hua county, a high risk area of esophageal cancer, were randomized into screening arm and control arm in a ratio of 1:1 and the total sample size is over 32,000 (\~16,000 per group). Participants in the screening arm will accept standard chromoendoscopy examination to detect early esophageal cancer and no screening were designed in the control arm. The incidence of advanced EC, EC-specific mortality and all-cause mortality will be compared within the two groups to test the hypothesis that endoscopic screening would alter the natural history of lesions in esophagus and the incidence of advanced stage EC, EC-specific mortality and all-cause mortality in the screening arm will be lower than the control group. Cost-effectiveness analysis will also be conducted to find the most cost-effective strategy of endoscopic screening in rural China.

Conditions

Interventions

PROCEDURE

Endoscopic Screening

1. Upper G.I. endoscopic examination with Lugols Iodine in esophagus 2. Biopsy at the visually abnormal sites 3. Pathologic examination of all biopsy tissue specimens 4. Subsequent re-examination and further medical services among individuals who already have high-grade lesions found at screening. 5. Advises of endoscopic or surgical treatment will be given to participants who are diagnosed of high grade upper G.I. lesions.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Yang Ke, M.D. · Laboratory of genetics, Peking University cancer Hospital and institute

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-01
Primary Completion
2022-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01688908 on ClinicalTrials.gov