← Back to Search

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,308 Total Patients Enrolled

Prasad G. Iyer, M.D.Principal InvestigatorMayo Clinic in Rochester

1 Previous Clinical Trials

1,350 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the availability of this research trial for prospective participants?

"Data available on clinicaltrials.gov verifies that this trial has open recruitment, beginning from October 1st 2023 and recently updated on October 3rd of the same year."

Answered by AI

Is this research endeavor enrolling senior citizens?

"The entry requirements for this medical trial specify that potential participants must be between 18 and 90 years old. Furthermore, there are 27 trials specifically targeting minors and 181 studies designed to investigate conditions affecting the elderly population."

Answered by AI

Could I potentially be a participant in this research endeavor?

"The requirements for inclusion in this medical trial is being aged between 18 and 90 with a diagnosis of barrett's esophagus. In total, 180 individuals will be accepted to the study."

Answered by AI

What is the enrollment rate for this clinical investigation?

"Affirmative. The clinical trial information hosted on the website notes that this medical study is in need of participants; it was first advertised October 1st 2023 and has since then been updated most recently on the 3rd of same month. A total 180 candidates are required to be sourced from two different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06071845.

All > Congenital Adrenal Hyperplasia