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

Sponsor

OHSU Knight Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02890979

Collaborator

Oregon Health and Science University (Other)

Enrollment

Location

Arm

14.2

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Barrett Esophagus Dysplasia Esophageal Adenocarcinoma Esophageal Squamous Cell Carcinoma Gastroesophageal Reflux Disease Metaplasia	Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Device: Swallowable Sponge Cell Sampling Device	N/A

Detailed Description

PRIMARY OBJECTIVES:

Determine the sensitivity and specificity of next generation sequencing for the detection of esophageal cancer from esophageal sponge cytology specimens.

SECONDARY OBJECTIVES:

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.
Determine the cost associated with esophageal cytology with next generation genome sequencing as a screening tool.
Continue to collect safety and tolerability data related to the use of the Oesotest esophageal sponge.
Determine the limitations of esophageal sponge cytology and future needs to improve this technique.
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 Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Actual Study Start Date :

Aug 3, 2016

Actual Primary Completion Date :

Oct 10, 2017

Actual Study Completion Date :

Oct 10, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Screening (cytology collection)

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

Other: Cytology Specimen Collection Procedure

Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device

Other Names:

Cytologic Sampling

Other: Laboratory Biomarker Analysis

Correlative studies

Other: Quality-of-Life Assessment

Ancillary studies

Other Names:

Quality of Life Assessment

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

Outcome Measures

Primary Outcome Measures

Detection of gene mutations using next generation sequencing (NGS) [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).

Secondary Outcome Measures

Sensitivity and specificity of the NGS probes to detect underlying esophageal dysplasia or cancer [Up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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