Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma

January 23, 2026 updated by: Mayo Clinic
This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The sponge on a string (SOS) device will be safely administered by a non-physician such as a nurse. Novel discriminant methylated DNA markers will be assayed on esophageal cytology specimens obtained from the SOS device to enable detection in Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection.

Study Type

Interventional

Enrollment (Estimated)

1550

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Completed
        • Mayo Clinic Arizona
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Completed
        • Mayo Clinic Jacksonville
    • Minnesota
      • Austin, Minnesota, United States, 55912
        • Recruiting
        • Mayo Clinic Health Systems - Austin
        • Contact:
        • Principal Investigator:
          • Eduardo Antpack, MD
      • Mankato, Minnesota, United States, 56001
        • Completed
        • Mayo Clinic Health Systems - Mankato
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Contact:
        • Principal Investigator:
          • Prasad G. Iyer, M.D.
        • Contact:
    • New York
      • New Hyde Park, New York, United States, 11040
        • Completed
        • Northwell Health
    • Texas
      • Dallas, Texas, United States, 75246
        • Completed
        • Baylor Scott & White Research Institute
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54701
        • Recruiting
        • Mayo Clinic Health System-Eau Claire
        • Contact:
      • La Crosse, Wisconsin, United States, 54601
        • Withdrawn
        • Mayo Clinic Health System-Franciscan Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria Aim1:

  • Male and female ages 50-85
  • Patients who have three or more risk factors for Barrett's Esophagus.

  • Gastroesophageal reflux disease defined by:

    • Diagnosis
    • Use of one of the following drugs >= 3 months over the last 5 years: omeprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole, lansoprazole, ranitidine, famotidine, cimetidine
    • prior endoscopic diagnosis of erosive esophagitis
  • Body mass index (BMI) >= 30

Exclusion Criteria Aim1 and Aim 3:

  • Previous history of:

    • esophageal adenocarcinoma/cancer
    • esophageal squamous carcinoma
    • endoscopic ablation for Barrett's esophagus
    • esophageal squamous dysplasia
  • Current treatment with oral anticoagulation including Warfarin, Coumadin
  • History of cirrhosis
  • History of esophageal/gastric varices
  • History of Barrett's esophagus
  • Prior endoscopy in the last 5 years

Inclusion criteria Aim 2 and Aim 3:

  • Subjects with known or suspected BE (cases).

    • Patient between the ages 18 - 90.
    • Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
    • Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
    • Undergoing clinically indicated endoscopy.

  • Subjects without known history of BE (controls).

    • Undergoing clinically indicated diagnostic endoscopy.

Exclusion criteria Aim 2:

  • Subjects with known BE.

    • Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD) alone will not be excluded.
    • Patients with history of esophageal resection for esophageal carcinoma.

  • For subjects with or without known evidence of BE (on history or review of medical records):

    • Pregnant or lactating females.
    • Patients who are unable to consent.
    • Patients with current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study).
    • History of eosinophilic esophagitis, achalasia.
    • Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings/biopsies only portion of the study).
    • Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure.
    • Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the sponge procedure.
    • Patients with history of known esophageal or gastric varices or cirrhosis.
    • Patients with history of surgical esophageal resection for esophageal carcinoma.
    • Patients with congenital or acquired bleeding diatheses.
    • Patients with a history of esophageal squamous dysplasia.
    • Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
    • Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Screening Population
Those that have gastroesophageal reflux or other risk factors for Barrett's Esophagus will be contacted and if agreeable undergo sponge capsule procedure and fill out questionnaires.
Device: Sponge Capsule
Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.
Other Names:
  • Cytosponge
  • EsophaCap
Other: Upper endoscopy - Barrett's Esophagus
Those that have a diagnosis of Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.
Device: Sponge Capsule
Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.
Other Names:
  • Cytosponge
  • EsophaCap
Other: Upper endoscopy - No Barrett's Esophagus
Those that have no known Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.
Device: Sponge Capsule
Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.
Other Names:
  • Cytosponge
  • EsophaCap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aim 1 - Screening Population
Time Frame: 5 years
To measure the positive and negative predictive value of the sponge capsule Barrett's esophagus test in a screening population.
5 years
Aim 2 - Case/Control Population BE Detection
Time Frame: 5 years
Compare the sensitivity and specificity of a predetermined BE prediction algorithm for those with and without GERD and assess the influence of other covariates (age, sex, ever smoking, ethnicity and BMI) on this algorithm.
5 years
Aim 3 - Dysplasia Detection Sensitivity and Specificity
Time Frame: 5 years
Measure the sensitivity and specificity of a predetermined MDM panel assayed on SOS specimens from BE patients identified in Aims 1 and 2, for the detection of HGD /EAC, using surveillance histology as the criterion standard.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aim 1 - Screening Population Predictive Value
Time Frame: 5 years
Compare positive predictive value and negative predictive value of the sponge capsule Barrett's Esophagus test between those with and without chronic GERD.
5 years
Aim 1 - Screening Population Safety and Tolerability of sponge capsule procedure
Time Frame: 5 years
Safety and tolerability of the sponge capsule device in a screening population as measured by a Tolerability Questionnaire with sponge capsule procedure. Participants will rate their tolerability by rating questions using a scale of 0-10 (0 is none and 10 is severe or 0 is good and 10 is not good).
5 years
Aim 2 - Case/Control Population Sensitivity and Specificity
Time Frame: 5 years
Validate specificity and sensitivity cut offs of a BE prediction algorithm in an independent patient cohort
5 years
Aim 3 - Dysplasia Detection Rate of Missed Dysplasia
Time Frame: 5 years
Measure diagnostic uncertainty bias in the criterion standard, specifically, the rate of dysplasia missed by surveillance histology
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Prasad G. Iyer, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

July 30, 2030

Study Completion (Estimated)

July 30, 2030

Study Registration Dates

First Submitted

May 15, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (Actual)

May 23, 2019

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-002629
  • R01CA241164 (U.S. NIH Grant/Contract)
  • NCI-2021-14395 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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