RecruitingNot ApplicableNCT05028725

Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma

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

Sponsor

University of California, San Francisco

Enrollment

289 participants

Start Date

May 16, 2022

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma Esophageal Squamous Dysplasia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Tanzanian study tests a non-invasive sponge device (called "EsophaCap") to detect esophageal squamous cell carcinoma (a type of throat/food-pipe cancer) at an earlier stage. The sponge is swallowed like a pill, collects cells, and is then retrieved for lab testing — a far simpler approach than standard endoscopy. **You may be eligible if...** - You are 18 or older and originally from Tanzania - You are being seen at Muhimbili National Hospital - You have a confirmed diagnosis of esophageal squamous cell carcinoma, OR - You are scheduled for an endoscopy with biopsy due to suspected esophageal cancer (symptoms like difficulty swallowing) - You are able to swallow liquids **You may NOT be eligible if...** - You are unable to swallow the capsule device - You cannot participate in a 20-minute interview and are not able to have a family member assist - You are unwilling to be contacted for a follow-up 7–10 days after the procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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