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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1550

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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