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
NCT02890979 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2020-11-25
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.
Conditions
- Barrett Esophagus
- Dysplasia
- Esophageal Adenocarcinoma
- Esophageal Squamous Cell Carcinoma
- Gastroesophageal Reflux Disease
- Metaplasia
Interventions
- 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
Sponsors & Collaborators
-
Oregon Health and Science University
collaborator OTHER -
OHSU Knight Cancer Institute
lead OTHER
Principal Investigators
-
James Dolan · OHSU Knight Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-08-03
- Primary Completion
- 2017-10-10
- Completion
- 2017-10-10
- FDA Device
- Yes
Countries
- United States
Study Locations
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