Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples

Launched by MAYO CLINIC · Oct 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new, easy-to-use tool called the Cytosponge to help detect Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC) in patients. Barrett's esophagus is a condition that can increase the risk of developing cancer in the esophagus. The Cytosponge is a small, swallowable device that collects samples from the esophagus without the need for traditional endoscopy, which is a more invasive procedure. The goal is to see if this method can make screening for these conditions easier and more accessible for patients who might be at risk.

To participate in the study, individuals should be between 18 and 90 years old and either have a known or suspected case of Barrett's esophagus or be undergoing an endoscopy for other reasons. Participants will simply swallow the Cytosponge, which will collect samples, and then they will undergo a standard endoscopy as part of their usual care. It's important to know that certain individuals, such as pregnant women or those with specific medical histories, may not be eligible to join the trial. This study aims to improve early detection of Barrett's esophagus and related conditions, potentially leading to better outcomes for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects with known or suspected Barrett's esophagus (BE) (cases)
• • Patients between the ages of 18-90.
• • Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
• • Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
• • Undergoing clinically indicated endoscopy.
• • Subjects without known history of BE (controls)
• • Undergoing clinically indicated diagnostic endoscopy
• Exclusion Criteria:
• • For subjects with or without known evidence of BE (on history or review of medical records)
• • Pregnant or lactating females.
• • Patients who are unable to consent.
• • Patients with current history of uninvestigated dysphagia.
• • History of eosinophilic esophagitis, achalasia.
• • Patients on oral anticoagulation including Coumadin, Warfarin.
• • Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the Cytosponge procedure.
• • Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the Cytosponge procedure.
• • Patients with history of known esophageal or gastric varices or cirrhosis.
• • Patients with history of surgical esophageal resection for esophageal carcinoma.
• • Patients with congenital or acquired bleeding diatheses.
• • Patients with a history of esophageal squamous dysplasia.
• • Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
• • Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.