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Clinical Trial 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 three 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


Clinical Trial Description

PRIMARY OBJECTIVE: I. To evaluate the sensitivity and specificity of a diagnostic strategy combining esophageal sponge sampling with the 'EsophaCap' sponge device with the EsoCAN assay, a novel molecular biomarker assay, among patients with histologically-confirmed ESCC and controls. SECONDARY OBJECTIVES: I. To evaluate the sensitivity and specificity of a diagnostic strategy combining esophageal sponge sampling with the 'EsophaCap' sponge device with the EsoCAN assay, among patients with histologically-confirmed ESD and controls. II. To evaluate the safety and feasibility of 'EsophaCap' a swallowable and retrievable sponge, as a non-invasive strategy for screening and early detection of ESCC and its precursor, ESD, in Tanzania. EXPLORATORY OBJECTIVES: I. To evaluate the sensitivity and specificity of a diagnostic strategy combining esophageal sponge sampling using the 'EsophaCap' with standard cytology, among patients with histologically-confirmed ESCC and controls. II. To evaluate the sensitivity and specificity of a diagnostic strategy combining esophageal sponge sampling using the 'EsophaCap' with standard cytology, among patients with histologically-confirmed ESD and controls. Participants will be on study for up to 38 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05028725
Study type Interventional
Source University of California, San Francisco
Contact Geoffrey Buckle, MD, MPH
Phone 508-380-9129
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date October 31, 2021
Completion date December 31, 2022

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