Study of Esophageal Squamous Dysplasia Prevalence at Tenwek Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 305
- 试验地点
- 1
- 主要终点
- Percentage rate of subjects with Esophageal Squamous dysplasia calculated as Prevalence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Percentage rate of subjects with Esophageal Squamous dysplasia calculated as Prevalence
时间窗: 2 years
次要结局
- percentage of subjects with mild esophageal squamous dysplasia calculated as a prevalence(2 years)
- 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)