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

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.

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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