Esophageal Cytology With FISH in Detecting Esophageal Cancer

NCT ID: NCT02100189

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cytology Specimen Collection Procedure

Intervention Type: OTHER

Undergo esophageal cytology collection

Esophagogastroduodenoscopy

Intervention Type: PROCEDURE

Undergo standard EGD or endoscopy

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Interventions

Cytology Specimen Collection Procedure

Undergo esophageal cytology collection

Intervention Type: OTHER

Esophagogastroduodenoscopy

Undergo standard EGD or endoscopy

Intervention Type: PROCEDURE

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

Cytologic Sampling; EGD

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

John Hunter

Interim Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Hunter

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

NCI-2014-00384

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB00009213

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA069533

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00009213

Identifier Type: -

Identifier Source: org_study_id