NCT05028725

Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma

Investigation of a Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 289 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the sensitivity and specificity of a diagnostic strategy combining esophageal sponge sampling with the 'EsophaCap' sponge device with use of the EsoCAN assay, a novel molecular biomarker assay, among patients with histologically-confirmed ESCC cases 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 use of the 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. Sensitivity and specificity of esophageal sponge sampling with standard cytological examination among histologically-confirmed ESCC cases and controls. II. Sensitivity and specificity of esophageal sponge sampling with standard cytological examination among histologically-confirmed ESD cases and controls. III. To examine methylation levels in new and previously identified genes among patients recruited as suspected ESCC cases who are found to have an alternative diagnosis, with the goal of optimizing the EsoCAN Assay. OUTLINE: Each participant will undergo esophageal sponge sampling suing the 'EsophaCap' sponge device. Participants will be on study for up to 38 days.

Conditions

• Esophageal Squamous Cell Carcinoma
• Esophageal Squamous Dysplasia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-05-16
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-08-31
• Last updated: 2025-03-30

Locations

2 sites across 1 country: Tanzania

Regulatory

• FDA-regulated device study