Esophageal Squamous Cell Cancer Surveillance With Cytosponge

NCT04192695 | Completed FDA Device

• 1 other identifier: 109/PB/2019
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acceptability of the Cytosponge™ cell collection device in patients with ESCC and high-risk for ESCC

  4 years

• 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

Study Arms (1)

Cytosponge

EXPERIMENTAL

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.

Device: Cytosponge cell collection device

Interventions

Cytosponge cell collection device 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.

Also known as: Gastroscopy with biopsies

Cytosponge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

Medical Centre for Postgraduate Education

Warsaw, 02-781, Poland

Location

Related Publications (1)

• Turkot MH, Yusuf A, Nowicki-Osuch K, Pilonis ND, Malhotra S, O'Donovan M, Mroz A, Lenarcik M, Wronska E, Mikula M, Zwolinski J, Wojtowicz-Popiel M, di Pietro M, Regula J, Kaminski MF, Fitzgerald RC, Januszewicz W. Feasibility and diagnostic accuracy of a capsule-sponge device for esophageal squamous neoplasia (EDEN trial). Clin Gastroenterol Hepatol. 2026 Jan 31:S1542-3565(26)00053-4. doi: 10.1016/j.cgh.2026.01.025. Online ahead of print.

  PMID: 41628756 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Gastroscopy; Biopsy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques

Study Officials

• Wladyslaw Januszewicz, M.D.

  Centre of Postgraduate Medical Education, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A prospective cohort study

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: December 10, 2019
• Study Start: January 1, 2021
• Primary Completion: February 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

PL (1)