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
NCT ID: NCT02890979
Last Updated: 2020-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2016-08-03
2017-10-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Screening (cytology collection)
Patients undergo cytology specimen collection procedure using a swallowable sponge cell sampling device.
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
Swallowable Sponge Cell Sampling Device
Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device
Interventions
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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
Swallowable Sponge Cell Sampling Device
Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 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
18 Years
ALL
No
Sponsors
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Oregon Health and Science University
OTHER
OHSU Knight Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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James Dolan
Role: PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute
Locations
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OHSU Knight Cancer Institute
Portland, Oregon, United States
Countries
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Other Identifiers
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NCI-2016-01318
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00015499
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00015499
Identifier Type: -
Identifier Source: org_study_id