search
Back to results

Swallowable Sponge Cell Sampling Device and Next Generation Sequencing in Detecting Esophageal Cancer in Patients With Low or High Grade Dysplasia, Barrett Esophagus, or Gastroesophageal Reflux Disease

Primary Purpose

Barrett Esophagus, Dysplasia, Esophageal Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cytology Specimen Collection Procedure
Laboratory Biomarker Analysis
Quality-of-Life Assessment
Swallowable Sponge Cell Sampling Device
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Barrett Esophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to understand and the willingness to sign a written informed consent document
  • Patients must be scheduled for a procedure capable of providing a definitive pathologic diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either upper endoscopy or surgical esophagectomy
  • One of the following inclusion criteria must be true for patient to be eligible for enrollment:
  • Subjects with known esophageal cancer (adenocarcinoma or squamous cell carcinoma)
  • Subjects with a history of low or high grade dysplasia
  • Subjects with risk factors for esophageal malignancy including Barrett?s esophagus and gastroesophageal reflux disease (GERD)

Exclusion Criteria:

  • Subjects that are unable to swallow a tablet/pill
  • Subjects with completely obstructing esophageal cancer
  • Subjects with known or suspected esophageal varices
  • 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
  • Any condition which, in the opinion of the investigator precludes the patient from completion of the study procedure

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening (cytology collection)

Arm Description

Patients undergo cytology specimen collection procedure using a swallowable sponge cell sampling device.

Outcomes

Primary Outcome Measures

Detection of gene mutations using next generation sequencing (NGS)
Will calculate the concordance of the gene mutations identified from the sponge sample to those identified from the tissue biopsy (control).

Secondary Outcome Measures

Sensitivity and specificity of the NGS probes to detect underlying esophageal dysplasia or cancer

Full Information

First Posted
September 1, 2016
Last Updated
November 23, 2020
Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University
search

1. Study Identification

Unique Protocol Identification Number
NCT02890979
Brief Title
Swallowable Sponge Cell Sampling Device and Next Generation Sequencing in Detecting Esophageal Cancer in Patients With Low or High Grade Dysplasia, Barrett Esophagus, or Gastroesophageal Reflux Disease
Official Title
Next Generation Sequencing of Esophageal Cytology for the Early Detection of Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 3, 2016 (Actual)
Primary Completion Date
October 10, 2017 (Actual)
Study Completion Date
October 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This pilot clinical trial studies how well a swallowable sponge cell sampling device and next generation sequencing work in detecting esophageal cancer in patients with low or high grade dysplasia, Barrett esophagus, or gastroesophageal reflux disease. Checking biomarkers in abnormal esophageal cells using a swallowable sponge cell sampling device and next generation sequencing may improve diagnosis and treatment of esophageal cancer.
Detailed Description
PRIMARY OBJECTIVES: I. Determine the sensitivity and specificity of next generation sequencing for the detection of esophageal cancer from esophageal sponge cytology specimens. SECONDARY OBJECTIVES: I. Determine the ability of next generation gene sequencing (NGS) of esophageal sponge samples to collect an adequate sample to detect mutations that are present in the underlying tissue. II. Determine the cost associated with esophageal cytology with next generation genome sequencing as a screening tool. III. Continue to collect safety and tolerability data related to the use of the Oesotest esophageal sponge. IV. Determine the limitations of esophageal sponge cytology and future needs to improve this technique. V. Use the data collected to design a larger screening trial to determine the ability of esophageal cytology with next generation sequencing to screen for esophageal cancer in the general population. OUTLINE: Patients undergo cytology specimen collection procedure using a swallowable sponge cell sampling device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus, Dysplasia, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Gastroesophageal Reflux Disease, Metaplasia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Screening (cytology collection)
Arm Type
Experimental
Arm Description
Patients undergo cytology specimen collection procedure using a swallowable sponge cell sampling device.
Intervention Type
Other
Intervention Name(s)
Cytology Specimen Collection Procedure
Other Intervention Name(s)
Cytologic Sampling
Intervention Description
Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Device
Intervention Name(s)
Swallowable Sponge Cell Sampling Device
Other Intervention Name(s)
Swallowable Sponge, Swallowable Sponge Device
Intervention Description
Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device
Primary Outcome Measure Information:
Title
Detection of gene mutations using next generation sequencing (NGS)
Description
Will calculate the concordance of the gene mutations identified from the sponge sample to those identified from the tissue biopsy (control).
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Sensitivity and specificity of the NGS probes to detect underlying esophageal dysplasia or cancer
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent document Patients must be scheduled for a procedure capable of providing a definitive pathologic diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either upper endoscopy or surgical esophagectomy One of the following inclusion criteria must be true for patient to be eligible for enrollment: Subjects with known esophageal cancer (adenocarcinoma or squamous cell carcinoma) Subjects with a history of low or high grade dysplasia Subjects with risk factors for esophageal malignancy including Barrett?s esophagus and gastroesophageal reflux disease (GERD) Exclusion Criteria: Subjects that are unable to swallow a tablet/pill Subjects with completely obstructing esophageal cancer Subjects with known or suspected esophageal varices 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 Any condition which, in the opinion of the investigator precludes the patient from completion of the study procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Dolan
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

Swallowable Sponge Cell Sampling Device and Next Generation Sequencing in Detecting Esophageal Cancer in Patients With Low or High Grade Dysplasia, Barrett Esophagus, or Gastroesophageal Reflux Disease

We'll reach out to this number within 24 hrs