Clinical trial NCT02890979: 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
Official title: Next Generation Sequencing of Esophageal Cytology for the Early Detection of Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett Esophagus
Dysplasia
Esophageal Adenocarcinoma
Esophageal Squamous Cell Carcinoma
Gastroesophageal Reflux Disease
Metaplasia
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2016-09-07
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection of gene mutations using next generation sequencing (NGS)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Sensitivity and specificity of the NGS probes to detect underlying esophageal dysplasia or cancer
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: James Dolan
role: PRINCIPAL_INVESTIGATOR
References: