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Procedure

Cytosponge Procedure for Barrett's Esophagus (SOS4C Trial)

N/A

Recruiting

Led By Prasad G. Iyer, MD

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

Must not have

Patients with congenital or acquired bleeding diatheses

Patients with a history of esophageal squamous dysplasia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have or might have Barrett's esophagus.

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My medical records show changes in my esophagus cells that could lead to cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bleeding disorder.

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I have had esophageal squamous dysplasia in the past.

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I have a history of eosinophilic esophagitis or achalasia.

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I am unable to give consent by myself.

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I have had chemotherapy or radiation for cancer in my chest area.

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I am taking blood thinners like Coumadin or Warfarin.

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I have a history of esophageal or gastric varices or cirrhosis.

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I have swallowing problems that haven't been checked by a doctor.

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I had surgery to remove part of my esophagus due to cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accuracy of the Oncoguard Esophagus (OGE) test

DNA yield from esophageal cytology samples collected with the Cytosponge device

Secondary study objectives

Tolerability of the Cytosponge device

Trauma to the esophagus from the passage of the Cytosponge device

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 11Eligibility criteria met