Esophageal Cytology With FISH in Detecting Esophageal Cancer in Participants Undergoing Esophago-Gastro-Duodenoscopy or Upper Endoscopy.

PRIMARY OBJECTIVES:

I. Determine if sponge cytology with FISH is a reliable screening tool for esophageal
dysplasia/cancer, and determine its sensitivity and specificity and compare it to the gold
standard procedure (the upper endoscopy).

SECONDARY OBJECTIVES:

I. Determine if the cytology screening with FISH biomarkers is less expensive and cost
effective than upper endoscopy for esophageal dysplasia/cancer.

II. Determine the limitations and future needs to improve this technique.

OUTLINE:

Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the
sponge is gently pulled out from the esophagus. Cytology samples from the sponge are
harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.

Inclusion Criteria:

- Subjects must have an endoscopy with confirmed study diagnosis (either normal or
abnormal); abnormal subjects must have a histological confirmation of the diagnosis

- Abnormal subjects will include patients with at least one of the following:

- Subjects with adenocarcinoma of the esophagus,"10030139"

- Subjects with adenocarcinoma of the gastroesophageal junction,"10066354"

- Subjects with squamous cell carcinoma of the esophagus,"10030186"

- Subjects with high grade dysplasia with or without Barrett's esophagus

- Normal subjects will include patients with at least one of the following:

- Subjects with a normal esophageal mucosa

- Subjects with esophagitis

- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status =< 3
(Karnofsky >= 30%) will be included

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Subjects that are unable to swallow a tablet/pill will be excluded

- Subjects with previous chemotherapy will be excluded

- Subjects with previous radiotherapy will be excluded

- Subjects with previous endoscopic treatment (e.g. endoscopic mucosal resection (EMR),
endoscopic submucosal dissection (ESD) or radiofrequency ablation (RFA) will be
excluded

- Subjects with a previous esophagectomy will be excluded

- Subjects with esophageal varices will be excluded

- Subjects unable to provide consent will be excluded

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to esophageal cell harvesting device compounds (sponge)

- History of allergic reactions attributed to compounds similar chemical or biologic
composition to lidocaine

- 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