NCT02890979

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2017

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

September 1, 2016

Last Update Submit

November 23, 2020

Conditions

Barrett EsophagusDysplasiaEsophageal AdenocarcinomaEsophageal Squamous Cell CarcinomaGastroesophageal Reflux DiseaseMetaplasia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Sensitivity and specificity of the NGS probes to detect underlying esophageal dysplasia or cancer

    Up to 2 years

Study Arms (1)

Screening (cytology collection)

EXPERIMENTAL

Patients undergo cytology specimen collection procedure using a swallowable sponge cell sampling device.

Other: Cytology Specimen Collection ProcedureOther: Laboratory Biomarker AnalysisOther: Quality-of-Life AssessmentDevice: Swallowable Sponge Cell Sampling Device

Interventions

Cytology Specimen Collection ProcedureOTHER

Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device

Also known as: Cytologic Sampling
Screening (cytology collection)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Screening (cytology collection)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Screening (cytology collection)
Swallowable Sponge Cell Sampling DeviceDEVICE

Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device

Also known as: Swallowable Sponge, Swallowable Sponge Device
Screening (cytology collection)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Barrett EsophagusAdenocarcinoma Of EsophagusEsophageal Squamous Cell CarcinomaGastroesophageal RefluxMetaplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEsophageal Motility DisordersDeglutition DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • James Dolan

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 7, 2016

Study Start

August 3, 2016

Primary Completion

October 10, 2017

Study Completion

October 10, 2017

Last Updated

November 25, 2020

Record last verified: 2020-11

Locations

US(1)