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

November 23, 2020 updated by: OHSU Knight Cancer Institute

Next Generation Sequencing of Esophageal Cytology for the Early Detection of Esophageal Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Screening (cytology collection)
Patients undergo cytology specimen collection procedure using a swallowable sponge cell sampling device.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Cytology Specimen Collection Procedure
Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device
Other Names:
  • Cytologic Sampling
Device: Swallowable Sponge Cell Sampling Device
Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device
Other Names:
  • Swallowable Sponge
  • Swallowable Sponge Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of gene mutations using next generation sequencing (NGS)
Time Frame: Up to 2 years
Will calculate the concordance of the gene mutations identified from the sponge sample to those identified from the tissue biopsy (control).
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity of the NGS probes to detect underlying esophageal dysplasia or cancer
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Collaborators

Oregon Health and Science University

Investigators

  • Principal Investigator: James Dolan, OHSU Knight Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2016

Primary Completion (Actual)

October 10, 2017

Study Completion (Actual)

October 10, 2017

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

November 25, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00015499 (Other Identifier: OHSU Knight Cancer Institute)
  • NCI-2016-01318 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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