Surveillance and Early Detection of Esophageal Squamous Cell Carcinoma With Minimally-invasive Cytosponge™ Cell Collection Device Coupled With Molecular Biomarkers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Esophageal Cancer
- Sponsor
- Centre of Postgraduate Medical Education
- Enrollment
- 178
- Locations
- 1
- Primary Endpoint
- Discovery of suitable biomarkers for squamous intraepithelial neoplasia to inform future trials.
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Wladyslaw Januszewicz
Principal Investigator
Centre of Postgraduate Medical Education
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)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Discovery of suitable biomarkers for squamous intraepithelial neoplasia to inform future trials.
Time Frame: 4 years
RNA-seq expression analysis will be used to measure the abundance of the previously identified biomarkers of squamous intraepithelial neoplasia, including genes TP53, NFE2L2, MLL2, ZNF750, NOTCH1, TFNAIP3, and CHN1. The study will include these biomarkers, but will not be limited to them.
Secondary Outcomes
- Safety of the Cytosponge™ cell collection device in patients with ESCC and high-risk for ESCC: rate of Participants with adverse events within 30 days after application(4 years)
- Acceptability of the Cytosponge™ cell collection device in patients with ESCC and high-risk for ESCC(4 years)