Clinical trial NCT02100189: Esophageal Cytology With FISH in Detecting Esophageal Cancer
Official title: Esophageal Cancer (10030139, 10066354) Screening With FISH in Esophageal Cytology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Dysplasia
Esophageal Adenocarcinoma
Esophageal Squamous Cell Carcinoma
Esophagitis
Gastroesophageal Reflux Disease
High Grade Dysplasia in Barrett Esophagus
Weight Loss
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of Sponge Cytology Using FISH
timeFrame: At the time of sponge cytology and EGD
measure: Specificity of Sponge Cytology Using FISH
timeFrame: At the time of sponge cytology and EGD
Secondary outcomes:
measure: Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
timeFrame: At the time of sponge cytology procedure
measure: Tolerability of FISH Spongy Cytology
timeFrame: After completion of FISH and EGD
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: John Hunter
role: PRINCIPAL_INVESTIGATOR
References: