Esophageal Squamous Cell Cancer Surveillance With Cytosponge
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Esophageal Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: A prospective cohort studyMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04192695
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Wladyslaw Januszewicz, M.D. Centre of Postgraduate Medical Education, Warsaw, Poland