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OpenTrials
Completed

NCT Number: NCT01981876

Study of Esophageal Squamous Dysplasia Prevalence at 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.

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Key information

Conditions

Esophageal Dysplasia Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma 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

20 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tenwek Hospital

Bomet, Riftvalley, 20400, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

  1. Percentage rate of subjects with Esophageal Squamous dysplasia calculated as Prevalence

    Time frame: 2 years

Secondary outcomes

  1. percentage of subjects with severe esophageal squamous dysplasia calculated as a prevalence

    Time frame: 2 years

  2. percentage of subjects with moderate esophageal squamous dysplasia calculated as a prevalence

    Time frame: 2 years

  3. percentage of subjects with mild esophageal squamous dysplasia calculated as a prevalence

    Time frame: 2 years

Other outcomes

  1. Distribution of dysplasia rate by age

    Time frame: 2 years

    An analysis of dysplasia rates in each percentile age group

  2. 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

  3. Distribution of dysplasia rate by gender

    Time frame: 2 years

    Distribution of dysplasia rates by sex of the subjects

Sponsors and collaborators

Lead sponsor

Tenwek Hospital

Other

Collaborators

  • AORTIC
  • Kenyatta National Hospital
  • Mayo Clinic

Registry information

Acronym: STEP

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 13, 2013
Registry last updated
Feb 27, 2015

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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