Esophageal Cytology With FISH in Detecting Esophageal Cancer

OHSU Knight Cancer Institute

Status

Completed

Conditions

Weight Loss

Esophagitis

Dysplasia

High Grade Dysplasia in Barrett Esophagus

Dysphagia

Gastroesophageal Reflux Disease

Esophageal Squamous Cell Carcinoma

Esophageal Adenocarcinoma

Treatments

Other: Cytology Specimen Collection Procedure

Procedure: Esophagogastroduodenoscopy

Other: Laboratory Biomarker Analysis

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02100189

NCI-2014-00384 (Registry Identifier)

P30CA069533 (U.S. NIH Grant/Contract)

IRB00009213 (Other Identifier)

Details and patient eligibility

About

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.

Full 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, compared to the gold standard procedure (upper endoscopy).

SECONDARY OBJECTIVES:

I. Determine if the cytology screening with FISH biomarkers is more cost effective than upper endoscopy for the screening of esophageal cancer and the surveillance of esophageal metaplasia and dysplasia.

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 pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects with known esophageal cancer diagnosed by previous endoscopy
- Adenocarcinoma
- Squamous cell carcinoma
Patients determined to be at risk for esophageal cancer:
- Subjects with a history of Barrett's esophagus
- Subjects with a history of low or high grade dysplasia
- Subjects with a history of gastroesophageal reflux disease (GERD)
- Subjects with a history of esophagitis
- Subjects with symptoms of esophageal cancer (EC) referred for endoscopy (new onset dysphagia, weight loss, etc)
Patients must be scheduled for a procedure capable of providing a definitive pathological diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either:
- Upper endoscopy
- Surgical esophagectomy
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 with severe, symptomatic dysphagia (unable to pass solids)
Subjects that are unable to swallow a tablet/pill for any reason
Subjects with a previous esophagectomy
Subjects with esophageal varices
Subjects unable to provide consent
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