NCT04192695

Esophageal Squamous Cell Cancer Surveillance With Cytosponge

Surveillance and Early Detection of Esophageal Squamous Cell Carcinoma With Minimally-invasive Cytosponge™ Cell Collection Device Coupled With Molecular Biomarkers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Centre of Postgraduate Medical Education · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Surveillance and early detection of esophageal squamous cell carcinoma with minimally-invasive Cytosponge™ cell collection device coupled with molecular biomarkers.

Detailed description

The goal of the study is to identify molecular abnormalities at each developmental stage of esophageal squamous cell carcinoma (low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and early squamous cell carcinoma) in order to establish new molecular biomarkers with potential for early detection and surveillance of the disease using the minimally-invasive Cytosponge™ cell collection device. Firstly, tissue samples after endoscopic treatment (endoscopic mucosal resection and endoscopic submucosal dissection) for squamous intraepithelial neoplasia and early squamous cell carcinoma will be analyzed with the use of the next-generation sequencing to identify potential diagnostic biomarkers. Afterward, patients with- and at risk- of esophageal squamous cell carcinoma will be recruited to undergo a diagnostic endoscopy with biopsies (the gold standard) and Cytosponge procedure. The diagnostic accuracy of Cytosponge coupled with molecular biomarkers will be evaluated to compare with the gold standard.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DEVICE	Cytosponge cell collection device	The Cytosponge™ is a minimally-invasive sampling device consisting of a polyurethane sponge compressed in a cellophane capsule attached to a string. When swallowed, the capsule dissolves in the stomach, releasing the cell collection sponge that expands to 3 cm in diameter. Next, a nurse or qualified medical technician retrieves the sponge by pulling back on the string and retracting it through the mouth. During extraction, the rough texture on the surface of the sponge collects epithelial cells in the cardia and along the entire length of the esophagus. Cytosponge™ has excellent safety profile and is approved by the Food and Drug Administration (FDA) and the Healthcare Products Regulatory Agency (HPRA) in the UK.

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-02-01
• Completion: 2024-05-01
• First posted: 2019-12-10
• Last updated: 2024-05-08

Locations

1 site across 1 country: Poland

Regulatory

• FDA-regulated device study