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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890979
• Other study ID #: STUDY00015499
• Secondary ID: NCI-2016-01318ST
• Status: Completed
• Phase: N/A
• Start date: August 3, 2016
• Est. completion date: October 10, 2017

Study information

• Verified date: November 2020
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 10, 2017
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Dysplasia
• Esophageal Adenocarcinoma
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma
• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Metaplasia

Intervention

Other:
• Cytology Specimen Collection Procedure
Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device
• Laboratory Biomarker Analysis
Correlative studies
• Quality-of-Life Assessment
Ancillary studies

Device:
• Swallowable Sponge Cell Sampling Device
Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to 2 years
Secondary	Sensitivity and specificity of the NGS probes to detect underlying esophageal dysplasia or cancer		Up to 2 years