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Completed

NCT Number: NCT04192695

Esophageal Squamous Cell Cancer Surveillance With Cytosponge

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Centre for Postgraduate Education

Warsaw, 02-781, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Gastroscopy with biopsies

Primary outcomes

  1. 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

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

    Time frame: 4 years

    % 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".

  2. 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

    Time frame: 4 years

    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

Sponsors and collaborators

Lead sponsor

Centre of Postgraduate Medical Education

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2019
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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