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Procedure

Cytosponge Procedure for Barrett's Esophagus (SOS4C Trial)

N/A
Recruiting
Led By Prasad G. Iyer, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with known or suspected Barrett's esophagus (BE) (cases)
Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

SOS4C Trial Summary

This trial studies a new minimally invasive test to detect Barrett's Esophagus, a precursor to cancer, to make it easier to detect and treat earlier.

Who is the study for?
This trial is for adults aged 18-90 with Barrett's Esophagus (BE) or suspected BE, who are undergoing endoscopy. It includes those without a known history of BE and excludes pregnant women, individuals unable to consent, patients on certain blood thinners unless stopped before the procedure, and those with specific esophageal conditions or past foregut cancer.Check my eligibility
What is being tested?
The trial tests a minimally invasive Cytosponge device against standard endoscopic assessment for detecting BE. The Cytosponge collects cells from the esophagus to identify biomarkers indicative of BE/esophageal adenocarcinoma using the Oncoguard Esophagus test.See study design
What are the potential side effects?
Potential side effects may include discomfort from swallowing the Cytosponge device and minor bleeding. There could also be risks associated with endoscopic procedures such as sore throat, infection risk, and very rarely perforation.

SOS4C Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have or might have Barrett's esophagus.
Select...
My medical records show changes in my esophagus cells that could lead to cancer.

SOS4C Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy of the Oncoguard Esophagus (OGE) test
DNA yield from esophageal cytology samples collected with the Cytosponge device
Secondary outcome measures
Tolerability of the Cytosponge device
Trauma to the esophagus from the passage of the Cytosponge device

SOS4C Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Known or Suspected Barrett's Esophagus (Case Arm)Experimental Treatment2 Interventions
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.
Group II: No Known Barrett's Esophagus (Control Arm)Active Control2 Interventions
Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,245 Previous Clinical Trials
3,783,272 Total Patients Enrolled
Prasad G. Iyer, M.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
1,350 Total Patients Enrolled
~104 spots leftby Jun 2025
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