NCT06418516Not yet recruiting
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 · Last updated 17 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- First submitted
- 13 May 2024
- Start date
- 1 Jun 2024
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Centre of Postgraduate Medical Education
- NCT number
- NCT06418516
What you commit to
- Study type: Interventional
- Planned participants: 340
- From 1 Jun 2024 to the primary completion date, 1 Feb 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients currently on anticoagulant treatment (warfarin, acenocoumarol) with no possibility of stopping / modification
Other illness
- 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).
Other
- Dysphagia grade ≥3 (able to swallow only liquid foods)
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.