Esophageal Squamous Cell Cancer Surveillance With Cytosponge

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04192695
• Other study ID #: 109/PB/2019
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: Centre of Postgraduate Medical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: May 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Esophageal Cancer

Intervention

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.

Locations

Country	Name	City	State
Poland	Medical Centre for Postgraduate Education	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discovery of suitable biomarkers for squamous intraepithelial neoplasia to inform future trials.	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.	4 years
Secondary	Acceptability of the Cytosponge™ cell collection device in patients with ESCC and high-risk for ESCC	% of Participants that have scored the Cytosponge experience of at least 6 points on a 0 to 10 Visual Analogue Scale (VAS) acceptability scale whereby 0 denotes "worst experience in life" and 10 denotes "best experience in life".	4 years
Secondary	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	The rate of Participants with adverse events within 30 days after application of the Cytosponge cell collection device, which is defined as any event that require admission to the hospital. E.g. retention of the device in the GI tract, chest pain or gastrointestinal bleeding requiring admission to the Ward	4 years