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Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma
Sponsor: University of California, San Francisco
Summary
In the current protocol, we propose a study to evaluate a novel, combined esophageal sponge-methylation biomarker strategy for the early detection of esophageal squamous cell carcinoma (ESCC) as well as its precursor, esophageal squamous dysplasia (ESD). This strategy leverages the 'EsophaCap', a swallowable, retrievable sponge, with subsequent evaluation of the sample using a novel molecular biomarker assay. This biomarker assay evaluates methylation levels in select genes, which have been shown to differ significantly between ESCC cases and controls in pilot studies. Detection of methylation markers highly associated with ESCC could help identify patients with concurrent ESCC or at high risk of imminently developing this condition. If successful, this strategy could result in a paradigm shift for esophageal cancer control strategies in Tanzania and other high-incidence ESCC regions.
Official title: Investigation of a Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
289
Start Date
2022-05-16
Completion Date
2025-12-31
Last Updated
2025-03-30
Healthy Volunteers
Yes
Interventions
EsophaCap Sponge
Non-invasive strategy to sample esophageal tissue
Chromoendoscopy
Lugol's iodine chromoendoscopy is a technique that is used to identify mucosal abnormalities of the esophagus
EsoCAN assay
Biomarker Test
Locations (2)
Muhimbili National Hospital (MNH)
Dar es Salaam, Mloganzila, Tanzania
Muhimbili National Hospital (MNH)
Dar es Salaam, Upganda, Tanzania