Esophageal Squamous Cell Cancer Surveillance With Cytosponge

Centre of Postgraduate Medical Education

Status: Completed

Conditions: Esophageal Cancer

Treatments: Device: Cytosponge cell collection device

Study type: Interventional

Funder types: Other

Identifiers

NCT04192695

109/PB/2019

Details and patient eligibility

About

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

Full 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.

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Patients with esophageal squamous cell cancer (ESCC):

• Patients ≥18 years of with adequate performance status for endoscopy
• Newly diagnosed ESCC suitable for endoscopic or oncological treatment (Rth/Chth)
• Patients currently undergoing oncological treatment (Rth/Chth)
• Consent to provide tissue samples for the study
• Dysphagia grade ≤2 (able to swallow mixed foods and tablets)

Patients at high risk for ESCC:

• Patients ≥18 years of age with adequate performance status for endoscopy
• Prior definitive treatment for head and neck cancer (cancer of the oral cavity, hypopharyngeal cancer, laryngeal carcinoma) and at least 12 months post-therapy (both Rth, Chth, and combination treatment)
• Prior definitive endoscopic treatment for early ESCC in the past (at least 6 months since completion)
• Consent to provide tissue samples for the study
• Dysphagia grade ≤2

Exclusion Criteria (for both groups of patients):

• Patients currently on anticoagulant treatment (warfarin, acenocoumarol) with no possibility of stopping / modification
• Dysphagia grade ≥3 (able to swallow only liquid foods)
• History of myocardial infarction or other cardiovascular event within 6 months of enrolment
• Neurological diseases associated with impaired swallowing
• Patients in long-term care or institutional care (physical, psycho-social disorders, intellectual disability).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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178 participants in 1 patient group

Cytosponge

Experimental group

Description:

This part of the study will have an active prospective recruitment of patients. Recruitment will involve two patient populations: 1. Patients with ESCC 2. Patients at high risk for ESCC Following inclusion in the study, subjects will be asked to complete a behavior questionnaire, have blood collected, and undergo a Cytosponge™ procedure followed by diagnostic gastroscopy using advanced imaging with biopsies. During gastroscopy, additional tissue samples will be collected for research purposes. These samples, along with cytological specimens from the Cytosponge™, will be analyzed to assess the diagnostic accuracy of biomarkers in the diagnosis of LG-IEN, HG-IEN, and ESCC.

Treatment:

Device: Cytosponge cell collection device