Gastroesophageal Reflux Disease Clinical Trial
Official title:
Next Generation Sequencing of Esophageal Cytology for the Early Detection of Esophageal Cancer
This pilot clinical trial studies how well a swallowable sponge cell sampling device and next generation sequencing work in detecting esophageal cancer in patients with low or high grade dysplasia, Barrett esophagus, or gastroesophageal reflux disease. Checking biomarkers in abnormal esophageal cells using a swallowable sponge cell sampling device and next generation sequencing may improve diagnosis and treatment of esophageal cancer.
PRIMARY OBJECTIVES: I. Determine the sensitivity and specificity of next generation sequencing for the detection of esophageal cancer from esophageal sponge cytology specimens. SECONDARY OBJECTIVES: I. Determine the ability of next generation gene sequencing (NGS) of esophageal sponge samples to collect an adequate sample to detect mutations that are present in the underlying tissue. II. Determine the cost associated with esophageal cytology with next generation genome sequencing as a screening tool. III. Continue to collect safety and tolerability data related to the use of the Oesotest esophageal sponge. IV. Determine the limitations of esophageal sponge cytology and future needs to improve this technique. V. Use the data collected to design a larger screening trial to determine the ability of esophageal cytology with next generation sequencing to screen for esophageal cancer in the general population. OUTLINE: Patients undergo cytology specimen collection procedure using a swallowable sponge cell sampling device. ;
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