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RECRUITING
NCT05028725
NA

Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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

DEVICE

EsophaCap Sponge

Non-invasive strategy to sample esophageal tissue

PROCEDURE

Chromoendoscopy

Lugol's iodine chromoendoscopy is a technique that is used to identify mucosal abnormalities of the esophagus

DEVICE

EsoCAN assay

Biomarker Test

Locations (2)

Muhimbili National Hospital (MNH)

Dar es Salaam, Mloganzila, Tanzania

Muhimbili National Hospital (MNH)

Dar es Salaam, Upganda, Tanzania