Study of Esophageal Squamous Dysplasia Prevalence at Tenwek Hospital

Esophageal Dysplasia Clinical Trial

— STEP  

Official title:

Study of Esophageal Squamous Dysplasia Prevalence at Tenwek Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981876
• Other study ID #: P172/06/2010
• Status: Completed
• Phase: N/A
• First received: October 29, 2013
• Last updated: February 26, 2015
• Start date: October 2010
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Tenwek Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophageal Dysplasia

Locations

Country	Name	City	State
Kenya	Tenwek Hospital	Bomet	Riftvalley

Sponsors (4)

Lead Sponsor	Collaborator
Tenwek Hospital	AORTIC, Kenyatta National Hospital, Mayo Clinic

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Distribution of dysplasia rate by age	An analysis of dysplasia rates in each percentile age group	2 years	No
Other	Distribution of unstained lesions on the esophagus by anatomic location	Distribution of unstained lesions on the esophagus based on their anatomic location after staining with lugol's iodine	2 years	No
Other	Distribution of dysplasia rate by gender	Distribution of dysplasia rates by sex of the subjects	2 years	No
Primary	Percentage rate of subjects with Esophageal Squamous dysplasia calculated as Prevalence		2 years	No
Secondary	percentage of subjects with severe esophageal squamous dysplasia calculated as a prevalence		2 years	No
Secondary	percentage of subjects with moderate esophageal squamous dysplasia calculated as a prevalence		2 years	No
Secondary	percentage of subjects with mild esophageal squamous dysplasia calculated as a prevalence		2 years	No