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Non-endoscopic EC Screening Program in Northern Iran

NCT02311712 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12000

Last updated 2025-04-16

No results posted yet for this study

Summary

The aim of this study is to assess the effects of implementation of a non-endoscopic esophageal cancer-screening program on outcomes of interest in an asymptomatic high-risk population in Golestan Province, Iran. Study population will be recruited in two arms. In the intervention arm, cytological examination of the esophagus will be performed using a capsule sponge device. Subjects in the control arm will receive no intervention. All participants will be followed for 5 years. The outcomes of interest, including the incidence of esophageal cancer as well as mortality rates, will be compared between the two groups.

Conditions

  • Esophageal Cancer

Interventions

DEVICE

Capsule sponge

Capsule sponge cytology examination coupled with H\&E staining analysed for the presence of atypia and p53 immunohistochemistry

Sponsors & Collaborators

  • International Agency for Research on Cancer

    collaborator OTHER

  • University of Cambridge

    collaborator OTHER

  • Golestan University of Medical sciences

    collaborator OTHER

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Reza Malekzadeh, MD · Tehran University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2025-12-31
Completion
2029-12-31

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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 NCT02311712 on ClinicalTrials.gov