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Esophageal Cytology With FISH in Detecting Esophageal Cancer

Primary Purpose

Dysphagia, Dysplasia, Esophageal Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cytology Specimen Collection Procedure
Esophagogastroduodenoscopy
Laboratory Biomarker Analysis
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Dysphagia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening (esophageal cytology, FISH)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Tolerability of FISH Spongy Cytology
Tolerability is defined as the patient's willingness to repeat procedure.

Full Information

First Posted
February 28, 2014
Last Updated
May 9, 2017
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02100189
Brief Title
Esophageal Cytology With FISH in Detecting Esophageal Cancer
Official Title
Esophageal Cancer (10030139, 10066354) Screening With FISH in Esophageal Cytology
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Dysplasia, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Esophagitis, Gastroesophageal Reflux Disease, High Grade Dysplasia in Barrett Esophagus, Weight Loss

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Screening (esophageal cytology, FISH)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cytology Specimen Collection Procedure
Other Intervention Name(s)
Cytologic Sampling
Intervention Description
Undergo esophageal cytology collection
Intervention Type
Procedure
Intervention Name(s)
Esophagogastroduodenoscopy
Other Intervention Name(s)
EGD
Intervention Description
Undergo standard EGD or endoscopy
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Sensitivity of Sponge Cytology Using FISH
Description
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.
Time Frame
At the time of sponge cytology and EGD
Title
Specificity of Sponge Cytology Using FISH
Description
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.
Time Frame
At the time of sponge cytology and EGD
Secondary Outcome Measure Information:
Title
Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Description
Descriptive statistics will be used to summarize all adverse events associated with FISH sponge cytology test.
Time Frame
At the time of sponge cytology procedure
Title
Tolerability of FISH Spongy Cytology
Description
Tolerability is defined as the patient's willingness to repeat procedure.
Time Frame
After completion of FISH and EGD

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Hunter
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Esophageal Cytology With FISH in Detecting Esophageal Cancer

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