Esophageal Squamous Cell Cancer Surveillance With Cytosponge

NCT ID: NCT04192695

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-05-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cytosponge

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.

Group Type: EXPERIMENTAL

Cytosponge cell collection device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Gastroscopy with biopsies

Eligibility 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

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre of Postgraduate Medical Education

OTHER

Sponsor Role: lead

Responsible Party

Wladyslaw Januszewicz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wladyslaw Januszewicz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Centre of Postgraduate Medical Education, Warsaw, Poland

Locations

Medical Centre for Postgraduate Education

Warsaw, , Poland

Countries

Poland

Other Identifiers

109/PB/2019

Identifier Type: -

Identifier Source: org_study_id