Esophageal Cytology With FISH in Detecting Esophageal Cancer in Participants Undergoing Esophago-Gastro-Duodenoscopy or Upper Endoscopy.
Conditions
Adenocarcinoma of the Gastroesophageal Junction - Dysplasia - Esophageal Adenocarcinoma - Esophageal Squamous Cell Carcinoma - High Grade Dysplasia in Barrett Esophagus
Conditions: official terms
Adenocarcinoma - Barrett Esophagus - Carcinoma, Squamous Cell - Esophageal Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening
Intervention
Name: Cytology Specimen Collection Procedure Type: Other
Name: Esophagogastroduodenoscopy Type: Procedure
Name: Laboratory Biomarker Analysis Type: Other
Overall Status
Recruiting
Summary
This clinical trial studies whether esophageal cytology plus fluorescence in situ hybridization (FISH) is equal to or better than esophago-gastro-duodenoscopy (EGD) or upper endoscopy for the early detection of esophageal cancer. Genes are the units of deoxyribonucleic acid (DNA) the chemical structure carrying genetic information that determine many human characteristics. Certain genes in cancer cells may determine how the tumor grows or spreads and how it may respond to different drugs. Part of this study is to test those genes in esophageal cells using FISH.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
OHSU Knight Cancer Institute
Portland, Oregon, United States
Status: Recruiting
Contact: John G. Hunter - 503-494-4937 - hunterj@ohsu.edu
Start Date
February 2014
Completion Date
December 2016
Sponsors
OHSU Knight Cancer Institute
Source
OHSU Knight Cancer Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page