Study of Esophageal Squamous Dysplasia Prevalence at Tenwek Hospital
STEP
1 other identifier
observational
305
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 29, 2013
CompletedFirst Posted
Study publicly available on registry
November 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 27, 2015
February 1, 2015
4.2 years
October 29, 2013
February 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage rate of subjects with Esophageal Squamous dysplasia calculated as Prevalence
2 years
Secondary Outcomes (3)
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 Outcomes (3)
Distribution of dysplasia rate by age
2 years
Distribution of unstained lesions on the esophagus by anatomic location
2 years
Distribution of dysplasia rate by gender
2 years
Eligibility Criteria
Adult Asymptomatic subjects residing within a 50 kilometer radius of Tenwek Hospital
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tenwek Hospitallead
- Kenyatta National Hospitalcollaborator
- Mayo Cliniccollaborator
- AORTICcollaborator
Study Sites (1)
Tenwek Hospital
Bomet, Riftvalley, 20400, Kenya
Biospecimen
Blood and Urine specimens
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael M Mwachiro, MBChB
Tenwek Hospital
- STUDY CHAIR
Russ E White, MD
Tenwek Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2013
First Posted
November 13, 2013
Study Start
October 1, 2010
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 27, 2015
Record last verified: 2015-02