Cytosponge Procedure for Barrett's Esophagus

(SOS4C Trial)

Recruiting at 4 trial locations

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Anticoagulants, Antiplatelets, Thrombin inhibitors

Disqualifiers: Pregnancy, Dysphagia, Cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

400 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are taking blood thinners like Coumadin, Warfarin, or certain other medications like Clopidogrel, Dabigatran, rivaroxaban, apixaban, or edoxaban, you will need to stop them for three to five days before the Cytosponge procedure.

What data supports the effectiveness of the Cytosponge Procedure treatment for Barrett's Esophagus?

The Cytosponge, a non-endoscopic device, has been shown to be safe, accurate, and acceptable to patients for diagnosing Barrett's Esophagus, a condition that can lead to esophageal cancer. Studies indicate it can effectively increase the detection of Barrett's Esophagus and may offer a less invasive and cost-effective alternative to traditional endoscopy. ^{1 2 3 4 5}

How is the Cytosponge Procedure different from other treatments for Barrett's Esophagus?

The Cytosponge Procedure is unique because it is a non-invasive test that uses a small sponge inside a capsule to collect cells from the esophagus, which are then tested for signs of Barrett's Esophagus. Unlike traditional endoscopy, it does not require sedation and can be done in a primary care setting, making it more accessible and less uncomfortable for patients. ^{1 2 3 5 6}

Research Team

Prasad G Iyer, MD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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.

Inclusion Criteria

I have or might have Barrett's esophagus.

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

Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record

Exclusion Criteria

I have a bleeding disorder.

I have had esophageal squamous dysplasia in the past.

I have a history of eosinophilic esophagitis or achalasia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection and Endoscopy

Participants undergo biopsy and sample collection with the Cytosponge followed by standard of care endoscopy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for trauma to the esophagus and tolerability of the Cytosponge device

7 days

1 visit (in-person)

Long-term Analysis

Analysis of DNA yield and methylated DNA markers from Cytosponge samples

12 months

Treatment Details

Interventions

• Cytosponge Procedure

Trial Overview 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.

Participant Groups

Group I: Known or Suspected Barrett's Esophagus (Case Arm) Experimental Treatment 2 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 Control 2 Interventions

Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.

Cytosponge Procedure is already approved in United Kingdom, European Union for the following indications:

Approved in United Kingdom as Cytosponge for:

• Detection of Barrett's esophagus
• Screening for esophageal adenocarcinoma

Approved in European Union as Cytosponge for:

• Detection of Barrett's esophagus
• Screening for esophageal adenocarcinoma

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

The Cytosponge-TFF3 test for diagnosing Barrett's oesophagus generally resulted in positive patient experiences, with a median satisfaction score of 1.7 out of 5, but 11.4% of participants reported a 'least positive' experience.

Key factors associated with a negative experience included high anxiety levels and failing to swallow the device on the first attempt, suggesting that addressing these issues prior to the procedure could enhance patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of the experience of a Cytosponge test: analysis of patient survey data from the BEST3 trial. Ghimire, B., Landy, R., Maroni, R., et al.[2023]

The Cytosponge device, combined with biomarkers like p53 overexpression and clinical factors, can effectively identify high-risk patients for Barrett's oesophagus, potentially reducing unnecessary endoscopies.

In a study involving 891 patients, those identified as high risk had a significant prevalence of high-grade dysplasia or cancer (52% in the training cohort), demonstrating the Cytosponge's potential to prioritize endoscopic interventions based on risk assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Cytosponge biomarker panel to prioritise endoscopic Barrett's oesophagus surveillance: a cross-sectional study followed by a real-world prospective pilot. Pilonis, ND., Killcoyne, S., Tan, WK., et al.[2023]

The Cytosponge test demonstrated a sensitivity of 74% and specificity of 85% for detecting residual Barrett's esophagus (BE) in patients who had undergone radiofrequency ablation, indicating it is a reliable non-invasive surveillance method.

Cytosponge-only surveillance was found to be more cost-effective than traditional endoscopy-only methods, requiring significantly fewer procedures while maintaining similar outcomes in terms of esophageal adenocarcinoma (EAC) cases and deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility and Cost-Effectiveness of a Nonendoscopic Approach to Barrett's Esophagus Surveillance After Endoscopic Therapy. Eluri, S., Paterson, A., Lauren, BN., et al.[2023]

The Cytosponge is a novel, patient-friendly device designed to efficiently sample the esophageal mucosa, showing promising results in detecting esophageal conditions compared to traditional endoscopy and biopsy methods.

High patient acceptability and the potential to reduce the need for costly endoscopic surveillance make the Cytosponge a significant advancement in the early detection of esophageal pathology, pending further validation in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a minimally invasive cell sampling device ('Cytosponge') in the diagnosis of esophageal pathology: a systematic review. Iqbal, U., Siddique, O., Ovalle, A., et al.[2019]

The BEST3 trial aims to evaluate the effectiveness of the Cytosponge-TFF3 test in increasing the diagnosis of Barrett's oesophagus (BE) among patients over 50 who have been on long-term acid suppressants, involving approximately 120 primary care practices in England.

Preliminary studies have shown that the Cytosponge-TFF3 test is safe, accurate, and well-accepted by patients, suggesting it could be a valuable tool for early detection of oesophageal cancer in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barrett's oESophagus trial 3 (BEST3): study protocol for a randomised controlled trial comparing the Cytosponge-TFF3 test with usual care to facilitate the diagnosis of oesophageal pre-cancer in primary care patients with chronic acid reflux. Offman, J., Muldrew, B., O'Donovan, M., et al.[2023]

The Cytosponge test, used to detect Barrett's oesophagus, was well accepted by patients, with 80% willing to undergo the procedure again despite some discomfort, particularly during removal.

Participants reported low levels of anxiety and high satisfaction with the test's convenience and staff competence, although there was an increase in perceived risk of oesophageal adenocarcinoma after the appointment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported experiences and views on the Cytosponge test: a mixed-methods analysis from the BEST3 trial. Maroni, R., Barnes, J., Offman, J., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Predictors of the experience of a Cytosponge test: analysis of patient survey data from the BEST3 trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Use of a Cytosponge biomarker panel to prioritise endoscopic Barrett's oesophagus surveillance: a cross-sectional study followed by a real-world prospective pilot. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Utility and Cost-Effectiveness of a Nonendoscopic Approach to Barrett's Esophagus Surveillance After Endoscopic Therapy. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a minimally invasive cell sampling device ('Cytosponge') in the diagnosis of esophageal pathology: a systematic review. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Barrett's oESophagus trial 3 (BEST3): study protocol for a randomised controlled trial comparing the Cytosponge-TFF3 test with usual care to facilitate the diagnosis of oesophageal pre-cancer in primary care patients with chronic acid reflux. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Patient-reported experiences and views on the Cytosponge test: a mixed-methods analysis from the BEST3 trial. [2022]