Early Detection of Esophageal Squamous Cancer With the Capsule Sponge Device
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre of Postgraduate Medical Education
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Capsule-sponge
Treatment groups
340 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Centre of Postgraduate Medical Education
Lead sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborator
Source ClinicalTrials.gov