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

Summary

This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE/esophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE/EAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of BE/EAC.

Eligibility

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.

Conditions5

Locations5 sites

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