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

OHSU Knight Cancer Institute

Status

Completed

Conditions

Dysplasia

Gastroesophageal Reflux Disease

Barrett Esophagus

Metaplasia

Esophageal Squamous Cell Carcinoma

Esophageal Adenocarcinoma

Treatments

Other: Quality-of-Life Assessment

Other: Laboratory Biomarker Analysis

Other: Cytology Specimen Collection Procedure

Device: Swallowable Sponge Cell Sampling Device

Study type

Interventional

Funder types

Other

Identifiers

NCT02890979

STUDY00015499 (Other Identifier)

NCI-2016-01318 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No 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