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

Not Applicable

Completed

• Conditions: Esophageal Adenocarcinoma; Barrett Esophagus; Esophageal Squamous Cell Carcinoma; Gastroesophageal Reflux Disease; Dysplasia; Metaplasia
• Interventions: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Device: Swallowable Sponge Cell Sampling Device

• Registration Number: NCT02890979
• Lead Sponsor: OHSU Knight Cancer Institute

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.

Study Timeline

• Study Start: 2016-08-03
• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-07
• Primary Completion: 2017-10-10
• Study Completion: 2017-10-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening (cytology collection)	Quality-of-Life Assessment	Patients undergo cytology specimen collection procedure using a swallowable sponge cell sampling device.
Screening (cytology collection)	Laboratory Biomarker Analysis	Patients undergo cytology specimen collection procedure using a swallowable sponge cell sampling device.
Screening (cytology collection)	Cytology Specimen Collection Procedure	Patients undergo cytology specimen collection procedure using a swallowable sponge cell sampling device.
Screening (cytology collection)	Swallowable Sponge Cell Sampling Device	Patients undergo cytology specimen collection procedure using a swallowable sponge cell sampling device.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Sensitivity and specificity of the NGS probes to detect underlying esophageal dysplasia or cancer	Up to 2 years

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States