Barrett EsophagusSOS4CNCT06071845
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
A study testing Cytosponge Procedure and Endoscopic Assessment in people with Barrett Esophagus and Barretts Esophagus With Dysplasia, run by Mayo Clinic at 5 sites in United States.
Trial summary
This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE/esophageal adenocarcinoma (EAC) detection are a… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Barrett Esophagus, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia
- What is being tested?
- Cytosponge Procedure and Endoscopic Assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Oct 2023to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 3 recruiting
- Terminated
Northwestern University
Chicago, Illinois, 60611
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Herbert C. Wolfsen, MD
- Completed
Long Island Jewish Medical Center | Northwell Health
New Hyde Park, New York, 11040
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Prasad G. Iyer, MD
- Recruiting
Mayo Clinic
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Prasad Iyer, MD
About this study
Official title: Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic Detection of Barrett's Esophagus With and Without Dysplasia
This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE/esophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE/EAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of BE/EAC.
Read the detailed description
PRIMARY OBJECTIVES:
- Measure Deoxyribonucleic acid (DNA) yield from esophageal cytology samples collected with the Cytosponge device.
II. Evaluate the methylated DNA markers (MDM) levels and accuracy of the Oncoguard Esophagus test (OGE test) for the detection of methylated DNA markers in Cytosponge collected esophageal cytology samples.
SECONDARY OBJECTIVES:
- Assess the tolerability of the Cytosponge device using a tolerability questionnaire II. Evaluate presence of any trauma to the esophagus from the passage of the Cytosponge device using the endoscopic injury score.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I: Patients with known or suspected Barrett's Esophagus undergo a biopsy and sample collection with the cytosponge followed by standard of care endoscopy and complete surveys while on study.
ARM II: Patients without known or suspected Barrett's Esophagus undergo a biopsy and sample collection with the cytosponge followed by standard of care endoscopy and complete surveys while on study.
- Conditions
- Barrett Esophagus, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia, Esophageal Adenocarcinoma
- Being tested
- Cytosponge Procedure, Endoscopic Assessment
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytosponge ProcedureDevice
Investigators will follow the Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.
Endoscopic AssessmentDiagnostic test
Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.
| Study group | Role | What they receive |
|---|---|---|
| Known or Suspected Barrett's Esophagus (Case Arm) | Experimental | Investigators will follow Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.c. After the sponge is retrieved, it will then be placed in a vial of cell preservative solution (PN DD-13631, Exact Sciences, Madison, WI) and shipped to the Exact Sciences laboratory for further processing and subsequent analysis. Receives: Device: Cytosponge Procedure; Diagnostic Test: Endoscopic Assessment |
| No Known Barrett's Esophagus (Control Arm) | Active comparator | Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment. Receives: Device: Cytosponge Procedure; Diagnostic Test: Endoscopic Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA yield from esophageal cytology samples collected with the Cytosponge device
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.
Measured: 12 months
Accuracy of the Oncoguard Esophagus (OGE) test
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.
Measured: 12 months
Secondary outcomes (2)
Tolerability of the Cytosponge device
Tolerability will be assessed with a 6-question Tolerability Questionnaire using a 0-10 pain scale where 0 is none and 10 is severe (0 is good and 10 is not good).
Measured: 7 days
Trauma to the esophagus from the passage of the Cytosponge device
Presence of any trauma from the passage of the sponge will be assessed and recorded photographically during the sedated endoscopy. This will be defined as: No evidence of trauma; Superficial mucosal abrasion without bleeding; Superficial mucosal tear abrasion with minimal oozing similar to that from biopsy; Deep mucosal abrasion without bleeding; Deep mucosal abrasion with greater than minimal oozing; or Bleeding requiring endoscopic therapy or perforation.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start16 Oct 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective multi-center case control study
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prasad G. Iyer, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071845
- Sponsor's protocol ID
- 22-010506
- Acronym
- SOS4C
- Status last verified
- May 2026
- First submitted
- 25 Sep 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic Detection of Barrett's Esophagus With and Without Dysplasia
- ClinicalTrials.gov ID
- NCT06071845
- Acronym / sponsor ID
- SOS4C / 22-010506
- Conditions
- Barrett Esophagus, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia, Esophageal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE/esophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE/EAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of BE/EAC.
Detailed description
PRIMARY OBJECTIVES:
- Measure Deoxyribonucleic acid (DNA) yield from esophageal cytology samples collected with the Cytosponge device.
II. Evaluate the methylated DNA markers (MDM) levels and accuracy of the Oncoguard Esophagus test (OGE test) for the detection of methylated DNA markers in Cytosponge collected esophageal cytology samples.
SECONDARY OBJECTIVES:
- Assess the tolerability of the Cytosponge device using a tolerability questionnaire II. Evaluate presence of any trauma to the esophagus from the passage of the Cytosponge device using the endoscopic injury score.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I: Patients with known or suspected Barrett's Esophagus undergo a biopsy and sample collection with the cytosponge followed by standard of care endoscopy and complete surveys while on study.
ARM II: Patients without known or suspected Barrett's Esophagus undergo a biopsy and sample collection with the cytosponge followed by standard of care endoscopy and complete surveys while on study.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective multi-center case control study
| Arm | Type | Receives |
|---|---|---|
| Known or Suspected Barrett's Esophagus (Case Arm) | Experimental | Device: Cytosponge Procedure, Diagnostic Test: Endoscopic AssessmentInvestigators will follow Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.c. After the sponge is retrieved, it will then be placed in a vial of cell preservative solution (PN DD-13631, Exact Sciences, Madison, WI) and shipped to the Exact Sciences laboratory for further processing and subsequent analysis. |
| No Known Barrett's Esophagus (Control Arm) | Active comparator | Device: Cytosponge Procedure, Diagnostic Test: Endoscopic AssessmentParticipants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with known or suspected Barrett's esophagus (BE) (cases)
- Subjects without known history of BE (controls)
Key exclusion criteria (14 listed)
- For subjects with or without known evidence of BE (on history or review of medical records)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytosponge ProcedureInvestigators will follow the Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device. | Device | Known or Suspected Barrett's Esophagus (Case Arm), No Known Barrett's Esophagus (Control Arm) |
| Endoscopic AssessmentParticipants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment. | Diagnostic test | Known or Suspected Barrett's Esophagus (Case Arm), No Known Barrett's Esophagus (Control Arm) |
Primary outcome
DNA yield from esophageal cytology samples collected with the Cytosponge device
Time frame: 12 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) test
Time frame: 12 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.
2 secondary outcomes
Tolerability of the Cytosponge device
Time frame: 7 days
Trauma to the esophagus from the passage of the Cytosponge device
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prasad G. Iyer, MD principal investigator
Mayo Clinic in Rochester
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytosponge Procedure and Endoscopic Assessment in people with Barrett Esophagus and Barretts Esophagus With Dysplasia, run by Mayo Clinic at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA yield from esophageal cytology samples collected with the Cytosponge device (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.