Esophageal Cancer (10030139, 10066354) Screening With FISH in Esophageal Cytology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- OHSU Knight Cancer Institute
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Sensitivity of Sponge Cytology Using FISH
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Sensitivity of Sponge Cytology Using FISH
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- Tolerability of FISH Spongy Cytology(After completion of FISH and EGD)
Investigators
John Hunter
Interim Dean
OHSU Knight Cancer Institute