Study of Esophageal Squamous Dysplasia Prevalence at Tenwek Hospital (STEP)

February 26, 2015 updated by: Tenwek Hospital
Esophageal squamous cell cancer (ESCC) is common in the developing world, and is the leading cancer diagnosis at Tenwek Hospital in southwestern Kenya. The investigators long-term goal is to understand the pathogenesis and risk factors for ESCC in Kenya, and to establish effective screening and prevention programs. The investigators hypothesize that asymptomatic esophageal squamous dysplasia (ESD) is common in their region, and the current protocol is designed to determine the prevalence of ESD in residents of southwestern Kenya.

Study Overview

Status

Completed

Conditions

Detailed Description

The prevalence of esophageal squamous dysplasia will be determined after evaluating pathology reports from unstained lesions and normal biopsies after staining with Lugol's iodine.

Study Type

Observational

Enrollment (Actual)

305

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
    • Riftvalley
      • Bomet, Riftvalley, Kenya, 20400
        • Tenwek Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult Asymptomatic subjects residing within a 50 kilometer radius of Tenwek Hospital

Description

Inclusion Criteria:

  • Age ≥ 20 years
  • No dysphagia (subjects will be asked "do you have trouble swallowing food or water? Do they get stuck inside after you swallow?" in their primary language

Exclusion Criteria:

  • Cardiac, respiratory, or metabolic disease that would increase the risk of endoscopy: history of myocardial infarction, arrhythmias, chronic obstructive pulmonary disease, diabetes, allergy to lidocaine.
  • Unable or unwilling to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage rate of subjects with Esophageal Squamous dysplasia calculated as Prevalence
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
percentage of subjects with severe esophageal squamous dysplasia calculated as a prevalence
Time Frame: 2 years
2 years
percentage of subjects with moderate esophageal squamous dysplasia calculated as a prevalence
Time Frame: 2 years
2 years
percentage of subjects with mild esophageal squamous dysplasia calculated as a prevalence
Time Frame: 2 years
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of dysplasia rate by age
Time Frame: 2 years
An analysis of dysplasia rates in each percentile age group
2 years
Distribution of unstained lesions on the esophagus by anatomic location
Time Frame: 2 years
Distribution of unstained lesions on the esophagus based on their anatomic location after staining with lugol's iodine
2 years
Distribution of dysplasia rate by gender
Time Frame: 2 years
Distribution of dysplasia rates by sex of the subjects
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tenwek Hospital

Collaborators

Mayo Clinic
Kenyatta National Hospital
AORTIC

Investigators

  • Principal Investigator: Michael M Mwachiro, MBChB, Tenwek Hospital
  • Study Chair: Russ E White, MD, Tenwek Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Estimate)

February 27, 2015

Last Update Submitted That Met QC Criteria

February 26, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P172/06/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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