Clinical trial · Interventional
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
NCT04192695CI-TRIAL-00076912completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Surveillance and early detection of esophageal squamous cell carcinoma with minimally-invasive Cytosponge™ cell collection device coupled with molecular biomarkers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytosponge cell collection device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cytosponge
- description
- 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.
- interventionNames
- Device: Cytosponge cell collection device
Primary outcomes (1)
- measure
- Discovery of suitable biomarkers for squamous intraepithelial neoplasia to inform future trials.
- timeFrame
- 4 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDTurkot 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 Sep;24(9):2411-2421. doi: 10.1016/j.cgh.2026.01.025. Epub 2026 Feb 26. PMID 41628756