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

Completed · Not applicable

Conditions studied: Barrett Esophagus, Dysplasia, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Gastroesophageal Reflux Disease, Metaplasia

In brief

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.

Key facts

Study ID

NCT02890979

Run by

OHSU Knight Cancer Institute

People needed

11

Starts

2016-08-03

Expected to finish

2017-10-10

Last updated by the study team

2020-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to understand and the willingness to sign a written informed consent document
• Patients must be scheduled for a procedure capable of providing a definitive pathologic diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either upper endoscopy or surgical esophagectomy
• One of the following inclusion criteria must be true for patient to be eligible for enrollment:
• Subjects with known esophageal cancer (adenocarcinoma or squamous cell carcinoma)
• Subjects with a history of low or high grade dysplasia
• Subjects with risk factors for esophageal malignancy including Barrett?s esophagus and gastroesophageal reflux disease (GERD)

You may not qualify if…

• Subjects that are unable to swallow a tablet/pill
• Subjects with completely obstructing esophageal cancer
• Subjects with known or suspected esophageal varices
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Any condition which, in the opinion of the investigator precludes the patient from completion of the study procedure

Where it is running

• OHSU Knight Cancer Institute — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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