Barrett EsophagusNCT03961945

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

A study testing Sponge Capsule in people with Barrett Esophagus and Esophageal Adenocarcinoma, run by Mayo Clinic at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Barrett Esophagus, Esophageal Adenocarcinoma
What is being tested?: Sponge Capsule
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,526 participants
Where: 8 sitesUnited States
Study dates: 1 Jul 2021to 25 Nov 2025
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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Body mass index (BMI) >= 30
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.

Who cannot join

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

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History of cirrhosis
History of esophageal/gastric varices
History of Barrett's esophagus
Prior endoscopy in the last 5 years
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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Mayo Clinic Health Systems - Austin
Austin, Minnesota, 55912
Baylor Scott & White Research Institute
Dallas, Texas, 75246
Mayo Clinic Health System-Eau Claire
Eau Claire, Wisconsin, 54701
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Mayo Clinic Health Systems - Mankato
Mankato, Minnesota, 56001
Northwell Health
New Hyde Park, New York, 11040
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Mayo Clinic Arizona
Scottsdale, Arizona, 85259

Other trials in United States

About this study

Read the 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.

Conditions: Barrett Esophagus, Esophageal Adenocarcinoma
Being tested: Sponge Capsule
Keywords: Barrett's Esophagus, Gastroesophageal Reflux, Reflux, Esophageal Cancer, Esophageal Adenocarcinoma
Medical subject headings: Barrett Esophagus, Adenocarcinoma Of Esophagus, Gastroesophageal Reflux, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sponge CapsuleDevice
Also called EsophaCap, Cytosponge
Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.

Study groups in NCT03961945
Study group	Role	What they receive
Screening Population	Other	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. Receives: Device: Sponge Capsule
Upper endoscopy - Barrett's Esophagus	Other	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. Receives: Device: Sponge Capsule
Upper endoscopy - No Barrett's Esophagus	Other	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. Receives: Device: Sponge Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Aim 1 - Screening Population
To measure the positive and negative predictive value of the sponge capsule Barrett's esophagus test in a screening population.
Measured: 5 years
Aim 2 - Case/Control Population BE Detection
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.
Measured: 5 years
Aim 3 - Dysplasia Detection Sensitivity and Specificity
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.
Measured: 5 years

Secondary outcomes (4)

Aim 1 - Screening Population Predictive Value
Compare positive predictive value and negative predictive value of the sponge capsule Barrett's Esophagus test between those with and without chronic GERD.
Measured: 5 years
Aim 1 - Screening Population Safety and Tolerability of sponge capsule procedure
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).
Measured: 5 years
Aim 2 - Case/Control Population Sensitivity and Specificity
Validate specificity and sensitivity cut offs of a BE prediction algorithm in an independent patient cohort
Measured: 5 years
Aim 3 - Dysplasia Detection Rate of Missed Dysplasia
Measure diagnostic uncertainty bias in the criterion standard, specifically, the rate of dysplasia missed by surveillance histology
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202125 Nov 2025

First posted23 May 2019
Study start1 Jul 2021
Primary completion25 Nov 2025
Study completion25 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Barrett EsophagusStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,526 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03961945
Sponsor's protocol ID: 19-002629
Other IDs: R01CA241164, NCI-2021-14395
Status last verified: Oct 2026
First submitted: 15 May 2019
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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