Study of Esophageal Squamous Dysplasia Prevalence at Tenwek Hospital

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01981876

Acronym

STEP

Enrollment

305

Registered

2013-11-13

Start date

2010-10-31

Completion date

2014-12-31

Last updated

2015-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Dysplasia

Keywords

Dysplasia, Esophageal Squamous Cell Carcinoma

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Percentage rate of subjects with Esophageal Squamous dysplasia calculated as Prevalence	2 years

Secondary

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

Other

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

Countries

Kenya

Outcome results