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Cytosponge Device for Esophageal Sample Analysis

This study is looking at a new, less invasive way to collect samples from your esophagus (the tube that connects your mouth to your stomach). It uses a device called Cytosponge, which is a small sponge you swallow that collects cells. Researchers want to see how much DNA they can get from these samples and how well a test called Oncoguard Esophagus (OGE) works with these samples to detect Barrett's esophagus (a condition where the lining of the esophagus changes) or esophageal cancer. You might be able to join if you are between 18 and 90 years old and have known or suspected Barrett's esophagus. The study aims to enroll 450 participants.

Study design
This interventional study plans to enroll 450 participants and assigns them to one of two groups: those with known or suspected Barrett's Esophagus and those without.
What's involved
You would undergo a biopsy, have samples collected with the Cytosponge device, and then have a standard endoscopy. You would also complete surveys during the study.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes of the study will be measured at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06071845

Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples

Recruiting
NAAges 18–90InterventionalScreening
Mayo Clinic
~450 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Cytosponge ProcedureEndoscopic Assessment

At a glance

Recruiting sites
3 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
DNA yield from esophageal cytology samples collected with the Cytosponge device
Measured over 12 months
+1 more outcome measured

Conditions

Barrett Esophagus
Barretts Esophagus With Dysplasia
Barrett's Esophagus Without Dysplasia
Esophageal Adenocarcinoma

Explore related trials

Barrett EsophagusEsophageal Adenocarcinoma

Where it's being run

5 sites across 5 states
Arizona1
Florida1
Illinois1
Minnesota1
New York1

Study leadership

  • Prasad G. Iyer, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subjects with known or suspected Barrett's esophagus (BE) (cases)
Patients between the ages of 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

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.
History of eosinophilic esophagitis, achalasia.
Patients on oral anticoagulation including Coumadin, Warfarin.
Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the Cytosponge 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 Cytosponge 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.

What this trial measures

  • DNA yield from esophageal cytology samples collected with the Cytosponge device12 months

    DNA concentration from samples collected with the Cytosponge device will be compared with DNA concentration previously observed from samples collected with the EsophaCap device on another study. The DNA concentration range for EsophaCap collected specimens ranged from 0.4 to 285ng/uL.

  • Accuracy of the Oncoguard Esophagus (OGE) test12 months

    Methylated DNA marker (MDM) levels and accuracy (sensitivity and specificity) will be evaluated to determine the accuracy of the OGE test using Cytosponge-collected esophageal samples. Accuracy will be established using upper endoscopy with pathology confirmed histology as the criterion standard for the diagnosis of Barrett's Esophagus (BE). The recently established algorithm for defining the OGE test as positive or negative (from EsophaCap samples collected from another study) will be utilized to adjudicate the Cytosponge samples as positive or negative. Accuracy of the OGE test for the Cytosponge device will be assessed in relation to the estimates and confidence intervals previously observed.