Clinical trial · Interventional
Early Detection of Esophageal Squamous Cancer With the Capsule Sponge Device
Early Detection of Esophageal Squamous Cell Carcinoma With the Capsule Sponge Device Coupled With Molecular Biomarkers and Machine Learning
- 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)
Esophageal squamous cell carcinoma accounts for \~90% of the nearly half-million annual incident cases of esophageal cancer worldwide. The high costs and invasiveness of upper endoscopy constitute a limitation in providing adequate surveillance for at-risk individuals, including those with previous head and neck cancer. The ANGELA study is a prospective evaluation of the minimally-invasive capsule-sponge device, coupled with tissue biomarkers (p53-immunohistochemistry), to detect squamous neoplasia in high-risk individuals.
Conditions
Conditions (3)
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 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capsule-sponge | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capsule-sponge
- description
- This part of the study will have an active prospective recruitment of patients. Recruitment will involve three patient populations: 1. Patients with ESCC 2. Patients at high risk for ESCC 3. Healthy controls Following inclusion in the study, subjects will be asked to complete a behavior questionnaire, have blood collected, and undergo a capsule-sponge 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 capsule-sponge, will be analyzed to assess the diagnostic accuracy of biomarkers in the diagnosis of esophageal squamous neoplasia.
- interventionNames
- Device: Capsule-sponge
Primary outcomes (1)
- measure
- Feasibility and diagnostic yield of capsule-sponge coupled with cellular atypia and p53-IHC analysis for detecting ESCC and its precursor lesions compared with endoscopy (gold standard)
- timeFrame
- 3 years
- description
- Sensitivity (%) and Specificity (%) of the capsule-sponge device in identifying patients with early squamous neoplasia (LG-IEN, HG-IEN, ESCC) as compared to the upper endoscopy with biopsies (gold standard)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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) 2. 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 3. Healthy controls - Patients ≥18 years old undergoing endoscopic evaluation for typical GI symptoms other than dysphagia (e.g., GERD, dyspepsia, etc.) without significant risk factors for ESCC Exclusion Criteria (for all 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 (0)
Data not yet available