NCT02890979

Swallowable Sponge Cell Sampling Device and Next Generation Sequencing in Detecting Esophageal Cancer in Patients With Low or High Grade Dysplasia, Barrett Esophagus, or Gastroesophageal Reflux Disease

Next Generation Sequencing of Esophageal Cytology for the Early Detection of Esophageal Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Barrett Esophagus
• Dysplasia
• Esophageal Adenocarcinoma
• Esophageal Squamous Cell Carcinoma
• Gastroesophageal Reflux Disease
• Metaplasia

Interventions

Type	Name	Description
OTHER	Cytology Specimen Collection Procedure	Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
DEVICE	Swallowable Sponge Cell Sampling Device	Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device

Timeline

• Start date: 2016-08-03
• Primary completion: 2017-10-10
• Completion: 2017-10-10
• First posted: 2016-09-07
• Last updated: 2020-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study