Esophageal Cytology With FISH in Detecting Esophageal Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Esophagitis; Weight Loss; Gastroesophageal Reflux Disease; Dysphagia; Esophageal Adenocarcinoma; Esophageal Squamous Cell Carcinoma; Dysplasia; High Grade Dysplasia in Barrett Esophagus
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Cytology Specimen Collection Procedure; Procedure: Esophagogastroduodenoscopy

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Screening (esophageal cytology, FISH); 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: Laboratory Biomarker Analysis; Correlative studies; Other: Cytology Specimen Collection Procedure; Undergo esophageal cytology collection; Other Names: Cytologic Sampling; Procedure: Esophagogastroduodenoscopy; Undergo standard EGD or endoscopy; Other Names: EGD

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: John Hunter, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 28, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (Estimate): March 31, 2014

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Body Weight; Gastroenteritis; Head and Neck Neoplasms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Body Weight Changes; Precancerous Conditions; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Gastroesophageal Reflux; Weight Loss; Esophageal Neoplasms; Barrett Esophagus; Esophageal Squamous Cell Carcinoma; Esophagitis
• Other Study ID Numbers: IRB00009213 (Other Identifier: OHSU Knight Cancer Institute); P30CA069533 (U.S. NIH Grant/Contract); NCI-2014-00384 (Registry Identifier: CTRP (Clinical Trial Reporting Program))