Esophageal Cytology With FISH in Detecting Esophageal Cancer

Not Applicable

Completed

Conditions: Dysphagia
Weight Loss
Esophagitis
Esophageal Adenocarcinoma
Dysplasia
Esophageal Squamous Cell Carcinoma
Gastroesophageal Reflux Disease
High Grade Dysplasia in Barrett Esophagus

Interventions: Other: Cytology Specimen Collection Procedure
Procedure: Esophagogastroduodenoscopy
Other: Laboratory Biomarker Analysis

Brief 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, 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Screening (esophageal cytology, FISH)	Cytology Specimen Collection Procedure	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.
Screening (esophageal cytology, FISH)	Laboratory Biomarker Analysis	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.
Screening (esophageal cytology, FISH)	Esophagogastroduodenoscopy	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity of Sponge Cytology Using FISH	At the time of sponge cytology and EGD	All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.
Specificity of Sponge Cytology Using FISH	At the time of sponge cytology and EGD	All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.

Secondary Outcome Measures

Name	Time	Method
Tolerability of FISH Spongy Cytology	After completion of FISH and EGD	Tolerability is defined as the patient's willingness to repeat procedure.
Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	At the time of sponge cytology procedure	Descriptive statistics will be used to summarize all adverse events associated with FISH sponge cytology test.