Clinical trial NCT04192695: Esophageal Squamous Cell Cancer Surveillance With Cytosponge
Official title: Surveillance and Early Detection of Esophageal Squamous Cell Carcinoma With Minimally-invasive Cytosponge™ Cell Collection Device Coupled With Molecular Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective cohort study
Primary purpose: DIAGNOSTIC

Brief summary: Surveillance and early detection of esophageal squamous cell carcinoma with minimally-invasive Cytosponge™ cell collection device coupled with molecular biomarkers.

Detailed description: The goal of the study is to identify molecular abnormalities at each developmental stage of esophageal squamous cell carcinoma (low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and early squamous cell carcinoma) in order to establish new molecular biomarkers with potential for early detection and surveillance of the disease using the minimally-invasive Cytosponge™ cell collection device. Firstly, tissue samples after endoscopic treatment (endoscopic mucosal resection and endoscopic submucosal dissection) for squamous intraepithelial neoplasia and early squamous cell carcinoma will be analyzed with the use of the next-generation sequencing to identify potential diagnostic biomarkers. Afterward, patients with- and at risk- of esophageal squamous cell carcinoma will be recruited to undergo a diagnostic endoscopy with biopsies (the gold standard) and Cytosponge procedure. The diagnostic accuracy of Cytosponge coupled with molecular biomarkers will be evaluated to compare with the gold standard.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria (for both groups of 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).

Primary outcomes:
measure: Discovery of suitable biomarkers for squamous intraepithelial neoplasia to inform future trials.
timeFrame: 4 years
Secondary outcomes:
measure: Acceptability of the Cytosponge™ cell collection device in patients with ESCC and high-risk for ESCC
timeFrame: 4 years
measure: Safety of the Cytosponge™ cell collection device in patients with ESCC and high-risk for ESCC: rate of Participants with adverse events within 30 days after application
timeFrame: 4 years
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical Centre for Postgraduate Education
Study officials:
affiliation: Centre of Postgraduate Medical Education, Warsaw, Poland
name: Wladyslaw Januszewicz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: