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Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma

NCT05028725 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Geoffrey Buckle, MD, MPH · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • Tanzania

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05028725 on ClinicalTrials.gov