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Study of Esophageal Squamous Dysplasia Prevalence at Tenwek Hospital

NCT ID: NCT01981876

Last Updated: 2015-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

305 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Esophageal Dysplasia

Keywords

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Dysplasia Esophageal Squamous Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kenyatta National Hospital

OTHER_GOV

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

AORTIC

UNKNOWN

Sponsor Role collaborator

Tenwek Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael M Mwachiro, MBChB

Role: PRINCIPAL_INVESTIGATOR

Tenwek Hospital

Russ E White, MD

Role: STUDY_CHAIR

Tenwek Hospital

Locations

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Tenwek Hospital

Bomet, Riftvalley, Kenya

Site Status

Countries

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Kenya

Other Identifiers

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P172/06/2010

Identifier Type: -

Identifier Source: org_study_id