Esophageal Cytology With FISH in Detecting Esophageal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Esophageal Cancer (10030139, 10066354) Screening With FISH in Esophageal Cytology

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

Intervention / Treatment
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* Other: Cytology Specimen Collection Procedure
* Procedure: Esophagogastroduodenoscopy
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening (esophageal cytology, FISH)<br>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. | Other: Cytology Specimen Collection Procedure<br>* Undergo esophageal cytology collection<br>* Other names: Cytologic Sampling;Procedure: Esophagogastroduodenoscopy<br>* Undergo standard EGD or endoscopy<br>* Other names: EGD;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Sponge Cytology Using FISH | 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. | At the time of sponge cytology and EGD | 
| Specificity of Sponge Cytology Using FISH | 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. | At the time of sponge cytology and EGD | 

Secondary Outcome Measures

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