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Early Detection of Esophageal Squamous Cancer With the Capsule Sponge Device

ConditionsEsophageal CancerHead and Neck CancerSquamous Cell Carcinoma
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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Capsule-sponge

    Device

    The capsule-sponge 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.

Treatment groups

340 Participants
are divided into 1 treatment group
Group A: Capsule-spongeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

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)

Time frame
3 years

Secondary outcomes

1

Acceptability of the capsule-sponge 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".

Time frame
3 years
2

Study on accuracy and feasibility of adding copy number profiling for aneuploidy assessment to the capsule-sponge samples

Within this outcome, we will clarify the optimal depth of sequencing, and we will then perform shallow whole genome sequencing (sWGS) on the samples collected in the training phase to input the copy-number variation (CNV) into the classification algorithm and evaluate the output as compared with the diagnosis of the patient. This will enable us to refine the classifications with the ultimate aim of using them predictively in a testing phase.

Time frame
3 years
3

Application of artificial intelligence on Cytosponge digitalized samples

To assess the utility of machine learning-based approaches to assist pathological assessment of the capsule-sponge samples for the applicability of the technology at scale. We will test the feasibility of applying the artificial intelligence (AI)-based technology onto digitalized capsule-sponge samples. The assessment will comprise of AI training phase and a validation period.

Time frame
3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre of Postgraduate Medical Education

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: