Cytosponge Procedure for Barrett's Esophagus

(SOS4C Trial)

Recruiting at 3 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new, less invasive method to detect Barrett's esophagus using a capsule with a sponge called a cytosponge. Participants swallow the sponge, which collects cells from the esophagus to check for changes that might indicate Barrett's esophagus or cancer. The trial includes two groups: one with individuals who have or might have Barrett's esophagus, and another with those who do not. Ideal candidates for this trial are individuals who either have Barrett's esophagus or are undergoing an endoscopy to check for it. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to less invasive diagnostic methods.

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 prior data suggests that the Cytosponge Procedure is safe for detecting Barrett's esophagus?

Research has shown that the Cytosponge procedure is safe and generally well-received by patients. A review of five large studies found that most people handle this procedure without major problems. Unlike traditional endoscopies, it doesn’t require sedation, making it simpler and easier for patients. The Cytosponge is a small, capsule-like device that patients swallow, which then collects cells from the food pipe. These cells help doctors check for Barrett's esophagus, a condition that can lead to esophageal cancer. Overall, studies indicate it’s a safe and effective alternative for screening, especially in primary care settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Cytosponge procedure is unique because it offers a less invasive way to diagnose Barrett's Esophagus compared to the standard sedated endoscopy. This innovative method involves swallowing a small capsule attached to a string, which expands into a sponge that collects cells from the esophagus lining as it's pulled back up. Researchers are excited about this approach because it can be done in a simple outpatient setting, potentially increasing patient comfort and reducing healthcare costs. Plus, it allows for earlier detection and monitoring of Barrett's Esophagus, which can lead to better management of the condition.

What evidence suggests that the Cytosponge Procedure is effective for detecting Barrett's Esophagus?

Research has shown that the Cytosponge procedure effectively detects Barrett's esophagus (BE). Studies have found that the Cytosponge, especially when paired with a specific test, can identify BE and even detect early changes that might lead to cancer. One study showed that the Cytosponge successfully collected cells from the esophagus in 75% of patients, providing reliable results. Participants in the "Known or Suspected Barrett's Esophagus" arm of this trial will undergo the Cytosponge procedure. In contrast, participants in the "No Known Barrett's Esophagus" control arm will receive traditional endoscopy. The Cytosponge offers a simpler and less invasive method for checking BE, potentially making screening easier and aiding in the early detection of BE in at-risk individuals. ^{2 3 5 6 7}

Who Is on the Research Team?

Prasad G Iyer, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12319419/

Diagnostic Test Accuracy of Cytosponge‐Trefoil Factor 3 ... The Cytosponge demonstrates high diagnostic accuracy for detecting BE, especially for any length of metaplasia. Further large‐scale studies are ...

2. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)01021-9/fulltext

Biomarker risk stratification with capsule sponge in the ... The risk-panel substantially enriches for dysplasia and capsule-sponge-based surveillance could be used in low-risk Barrett's oesophagus in lieu of endoscopy.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8352994/

UTILITY AND COST-EFFECTIVENESS OF A NON- ... Results: Of 234 patients, Cytosponge® adequately sampled the distal esophagus in 175 (75%). Of the 142 with both endoscopic and histologic data, 19 (13%) had ...

4. shtg.scot shtg.scot/media/2410/20231002-capsule-sponge-assessment-v10.pdf

Capsule sponge technologies for the detection of Barrett's ... A well conducted systematic review assessed the efficacy of Cytosponge™ plus TFF3 testing, compared with endoscopic biopsy (assumed 100 % ...

5. cancerresearchuk.org cancerresearchuk.org/health-professional/diagnosis/investigations/capsule-sponge

Capsule sponge testing and oesophageal cancer diagnosis Data suggest that Barrett's oesophagus may be missed in 19-27% of those with a negative capsule sponge result [2,4]. Safety netting those with a negative ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6370042/

Cytosponge®: a systematic review of multi-center data This technical review of five large prospective studies on the performance of the Cytosponge® showed that it is a safe procedure with good acceptability ratings ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1521691825000162

Barrett's esophagus screening: Current modalities, risk ... Cytosponge and Endosign, Esocheck, and EsophaCap do not require sedation, are safe, and can be performed by non-physicians in the primary care setting. This ...