Early Detection of Esophageal Squamous Cancer With the Capsule Sponge Device
ANGELA
1 other identifier
interventional
340
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2024
CompletedFirst Posted
Study publicly available on registry
May 17, 2024
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
May 17, 2024
January 1, 2024
2.7 years
May 13, 2024
May 13, 2024
Conditions
Keywords
Outcome Measures
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)
3 years
Secondary Outcomes (3)
Acceptability of the capsule-sponge device in patients with ESCC and high-risk for ESCC
3 years
Study on accuracy and feasibility of adding copy number profiling for aneuploidy assessment to the capsule-sponge samples
3 years
Application of artificial intelligence on Cytosponge digitalized samples
3 years
Study Arms (1)
Capsule-sponge
EXPERIMENTALThis 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wladyslaw Januszewicz, M.D., PhD
Centre of Postgraduate Medical Education, Warsaw, Poland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2024
First Posted
May 17, 2024
Study Start
June 1, 2024
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
May 17, 2024
Record last verified: 2024-01