Cytosponge Procedure for Barrett's Esophagus
(SOS4C Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Must not be taking: Anticoagulants, Antiplatelets, Thrombin inhibitors
Disqualifiers: Pregnancy, Dysphagia, Cirrhosis, others
No Placebo Group
Approved in 2 Jurisdictions
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.
12345How 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.
12356Eligibility 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.
I am between 18 and 90 years old.
+4 more
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.
+10 more
Trial 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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Long Island Jewish Medical Center | Northwell HealthNew Hyde Park, NY
Mayo ClinicScottsdale, AZ
Northwestern UniversityChicago, IL
Mayo Clinic in FloridaJacksonville, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
Predictors of the experience of a Cytosponge test: analysis of patient survey data from the BEST3 trial. [2023]The Cytosponge is a cell-collection device, which, coupled with a test for trefoil factor 3 (TFF3), can be used to diagnose Barrett's oesophagus, a precursor condition to oesophageal adenocarcinoma. BEST3, a large pragmatic, randomised, controlled trial, investigated whether offering the Cytosponge-TFF3 test would increase detection of Barrett's. Overall, participants reported mostly positive experiences. This study reports the factors associated with the least positive experience.
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]Endoscopic surveillance is recommended for patients with Barrett's oesophagus because, although the progression risk is low, endoscopic intervention is highly effective for high-grade dysplasia and cancer. However, repeated endoscopy has associated harms and access has been limited during the COVID-19 pandemic. We aimed to evaluate the role of a non-endoscopic device (Cytosponge) coupled with laboratory biomarkers and clinical factors to prioritise endoscopy for Barrett's oesophagus.
Utility and Cost-Effectiveness of a Nonendoscopic Approach to Barrett's Esophagus Surveillance After Endoscopic Therapy. [2023]A non-endoscopic approach to Barrett's esophagus (BE) surveillance after radiofrequency ablation (RFA) would offer a less invasive method for monitoring. We assessed the test characteristics and cost-effectiveness of the Cytosponge (Medtronic, Minneapolis, MN) in post-RFA patients.
Safety and efficacy of a minimally invasive cell sampling device ('Cytosponge') in the diagnosis of esophageal pathology: a systematic review. [2019]Esophageal adenocarcinoma is an increasingly common cause of morbidity and mortality in developed countries. Most cases are considered the consequence of chronic gastroesophageal reflux disease, with subsequent Barrett's metaplasia and dysplasia. Because progression from Barrett's metaplasia to cancer occurs over many years, endoscopic screening and surveillance programs have been established, albeit with little or no consideration for cost-effectiveness. As an alternative to the expensive and resource-demanding endoscopic surveillance, the Cytosponge has been developed to sample the esophageal mucosa efficiently. The device is a compressed mesh sponge encapsulated in an ingestible gelatin pill attached to a string. After swallowing, the capsule dissolves allowing the sponge to expand in the stomach. As it is pulled out, cells are collected from the esophagogastric junction and throughout the esophagus. The cellular samples can be analyzed by cytology, immunohistochemistry, and molecular markers. We conducted a systematic review of all recent relevant studies to help define the role of this novel technology, including studies of screening and surveillance of Barrett's esophagus, esophageal squamous dysplasia detection, detection of eosinophilic esophagitis, and evaluation of benign esophageal diseases. With the major limitation that most studies were performed by a single investigative group that developed the technology, the device yielded overall impressive results against the endoscopy/biopsy gold standard. Patient acceptability was high. If these promising early results are validated by other investigators in other populations, the Cytosponge represents an important new advance in the detection of esophageal pathology that could potentially decrease the burden of endoscopic esophageal sampling.
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]Early detection of oesophageal cancer improves outcomes; however, the optimal strategy for identifying patients at increased risk from the pre-cancerous lesion Barrett's oesophagus (BE) is not clear. The Cytosponge, a novel non-endoscopic sponge device, combined with the biomarker Trefoil Factor 3 (TFF3) has been tested in four clinical studies. It was found to be safe, accurate and acceptable to patients. The aim of the BEST3 trial is to evaluate if the offer of a Cytosponge-TFF3 test in primary care for patients on long term acid suppressants leads to an increase in the number of patients diagnosed with BE.
Patient-reported experiences and views on the Cytosponge test: a mixed-methods analysis from the BEST3 trial. [2022]The BEST3 trial demonstrated the efficacy and safety of the Cytosponge-trefoil factor 3, a cell collection device coupled with the biomarker trefoil factor 3, as a tool for detecting Barrett's oesophagus, a precursor of oesophageal adenocarcinoma (OAC), in primary care. In this nested study, our aim was to understand patient experiences.