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Surveillance and early detection of esophageal squamous cell carcinoma with minimally-invasive Cytospongeâ„¢ cell collection device coupled with molecular biomarkers.
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 Cytospongeâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cytosponge | Experimental | This part of the study will have an active prospective recruitment of patients. Recruitment will involve two patient populations:
Following inclusion in the study, subjects will be asked to complete a behavior questionnaire, have blood collected, and undergo a Cytospongeâ„¢ 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 Cytospongeâ„¢, will be analyzed to assess the diagnostic accuracy of biomarkers in the diagnosis of LG-IEN, HG-IEN, and ESCC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytosponge cell collection device | Device | The Cytospongeâ„¢ 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. Cytospongeâ„¢ has excellent safety profile and is approved by the Food and Drug Administration (FDA) and the Healthcare Products Regulatory Agency (HPRA) in the UK. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the Cytospongeâ„¢ 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 |
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Inclusion Criteria:
Patients with esophageal squamous cell cancer (ESCC):
Patients at high risk for ESCC:
Exclusion Criteria (for both groups of patients):
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| Name | Affiliation | Role |
|---|---|---|
| Wladyslaw Januszewicz, M.D. | Centre of Postgraduate Medical Education, Warsaw, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Centre for Postgraduate Education | Warsaw | 02-781 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41628756 | Derived | 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 Feb 26:S1542-3565(26)00053-4. doi: 10.1016/j.cgh.2026.01.025. Online ahead of print. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005773 | Gastroscopy |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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A prospective cohort study
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|
| Safety of the Cytospongeâ„¢ 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 |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |