Sponge Capsule Diagnosis for Esophageal Cancer

Recruiting at 2 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: Barrett's esophagus, Dysphagia, Cirrhosis, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

1550 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new sponge capsule device to determine its accuracy in detecting Barrett's Esophagus and related conditions, such as dysplasia (abnormal cells) or adenocarcinoma (a type of cancer), particularly in individuals with chronic heartburn. Participants may undergo both the sponge capsule procedure and a traditional upper endoscopy, depending on their medical history. Ideal candidates include those with frequent heartburn who use specific medications for acid reflux or have a history of erosive esophagitis (irritation or damage to the esophagus). As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new, less invasive diagnostic methods.

Will I have to stop taking my current medications?

If you are taking blood thinners like Coumadin, Warfarin, or certain antiplatelet and thrombin inhibitor medications, you may need to stop them for three to five days before the procedure. For other medications, the trial protocol does not specify any requirements.

What prior data suggests that the sponge capsule device is safe for detecting esophageal conditions?

Research shows that the sponge capsule, known as the Cytosponge, is safe to use. Many studies have found that people generally tolerate it well in various healthcare settings, and users typically find it acceptable. Importantly, these studies have not identified any major safety concerns. The sponge capsule is a simple device that collects cells from the esophagus, the tube connecting the throat to the stomach, making it less invasive than methods like endoscopy. Overall, evidence suggests that the sponge capsule is a safe choice for consideration. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the sponge capsule technique for diagnosing esophageal cancer because it offers a non-invasive alternative to traditional endoscopy. Unlike standard endoscopic procedures, which require sedation and can be uncomfortable, the sponge capsule is simply swallowed and collects cells from the esophagus as it travels down. This method could make screening for esophageal conditions like Barrett's Esophagus more accessible and less intimidating for patients, potentially leading to earlier detection and treatment.

What evidence suggests that the sponge capsule device is effective for detecting Barrett's Esophagus?

Research has shown that the sponge capsule effectively detects Barrett's Esophagus, a condition that can lead to esophageal cancer. In this trial, participants will undergo the sponge capsule procedure as part of different study arms. Studies have found that the sponge capsule can identify patients at low risk of developing more serious issues like dysplasia or esophageal cancer. This suggests the sponge capsule might help find people who don't need more invasive tests like an endoscopy. Catching esophageal adenocarcinoma (a type of cancer) early is important because it greatly improves treatment success. Some evidence suggests that Barrett's Esophagus might be missed in a small number of cases with a negative sponge capsule result, but overall, it is seen as a promising tool for screening and assessing risk. ^{2 5 6 7 8}

Who Is on the Research Team?

Prasad G Iyer, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for men and women aged 50-85 who are primary care patients at Mayo Clinic Rochester or its Health Systems. It's specifically for those with three or more risk factors for Barrett's Esophagus, which often includes chronic acid reflux.

Inclusion Criteria

Participants are patients of Mayo Clinic Rochester or Mayo Clinic Health Systems.

I have three or more risk factors for Barrett's Esophagus.

I am between 50 and 85 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Procedure

Participants undergo the sponge capsule procedure and fill out questionnaires

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Sponge Capsule

Trial Overview The study is testing a sponge capsule device to see if it can accurately detect Barrett's Esophagus and any early signs of esophageal cancer in people, particularly among those with long-term gastroesophageal reflux disease.

How Is the Trial Designed?

Group I: Upper endoscopy - No Barrett's Esophagus Experimental Treatment 1 Intervention

Those that have no known Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.

Group II: Upper endoscopy - Barrett's Esophagus Experimental Treatment 1 Intervention

Those that have a diagnosis of Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.

Group III: Screening Population Experimental Treatment 1 Intervention

Those that have gastroesophageal reflux or other risk factors for Barrett's Esophagus will be contacted and if agreeable undergo sponge capsule procedure and fill out questionnaires.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Sponge cytology is a safe and well-tolerated method for collecting esophageal cell samples, with no complications reported in a study of 50 patients.

However, the use of p53 fluorescent in situ hybridization did not enhance the sensitivity for detecting esophageal cancer or related abnormalities, indicating that while sponge cytology is promising, its diagnostic effectiveness may need further improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sponge Sampling with Fluorescent In Situ Hybridization as a Screening Tool for the Early Detection of Esophageal Cancer. Haisley, KR., Dolan, JP., Olson, SB., et al.[2022]

Sponge cytology is a highly effective and safe method for obtaining esophageal specimens, with 100% success in swallowing the sponge and satisfactory evaluation material from all participants.

The results showed that 86.6% of smears were negative for lesions, while 10% showed intestinal metaplasia, and 1.7% indicated high-grade lesions or squamous cell carcinoma, demonstrating good agreement with endoscopic findings and suggesting its potential as a primary screening tool in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esophageal cytology sponge diagnostic test results in kenyatta national referral hospital, kenya. Muriithi, RW., Muchiri, LW., Lule, GN.[2014]

Endoscopic implantation of esophageal prostheses provides immediate relief from dysphagia in 90% of patients, making it the preferred palliative treatment for esophageal carcinoma.

While effective, long-term complications from prosthesis implantation require reintervention in 30% of cases, highlighting the need for careful management of patients receiving this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Palliative options for esophageal carcinoma]. Hagenmüller, F.[2018]

The sponge smear technique was studied in 44 patients with esophageal carcinoma and 21 with gastric fundus cancer, showing effectiveness in diagnosing esophageal tumors compared to traditional esophageal washings.

This technique offers several advantages over esophageal washings, suggesting it may provide more reliable cytological results for patients with esophageal tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnosis of cancer of the esophagus by sponge smears (II)]. [2007]

In a study of 109 patients with primary esophageal small cell carcinoma (PESCC), those who underwent radical esophagectomy combined with postoperative chemotherapy had significantly better survival outcomes, with a median survival time of 17.0 months compared to 7.0 months for those who did not receive chemotherapy.

The study found that the pathological N stage and the use of postoperative chemotherapy were independent prognostic factors, highlighting the aggressive nature of PESCC and the importance of multimodal treatment for improving patient prognosis, especially in earlier stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical treatment and prognostic analysis of 109 patients with primary esophageal small cell carcinoma]. Zhang, BH., Yang, WJ., Zhao, L., et al.[2018]

The Cytosponge device, used for collecting esophageal cells, was found to be safe with only two minor adverse events reported out of 2672 procedures, indicating a low risk associated with its use.

Patients rated the acceptability of the Cytosponge higher than that of unsedated endoscopy, with a median score of 6.0, suggesting it is a more comfortable option for diagnosing conditions like Barrett's esophagus and eosinophilic esophagitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Acceptability of Esophageal Cytosponge Cell Collection Device in a Pooled Analysis of Data From Individual Patients. Januszewicz, W., Tan, WK., Lehovsky, K., et al.[2021]

In a study involving 57 patients with inoperable esophageal and cardia carcinoma, the new ESKA-Buess endoprosthesis significantly improved swallowing ability, with 61% of patients able to swallow normally after treatment.

The procedure had a low mortality rate of 3.5%, and patients had an average survival of approximately 3 months, indicating that the endoprosthesis is a relatively safe option for managing dysphagia in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Endotube insertion for palliation of esophageal and cardia cancer: experiences with a new endoprosthesis]. Van Maercke, P., Schellong, H.[2009]

The Cytosponge™ device is a safe and well-tolerated method for assessing treatment response in patients with oesophageal squamous cell carcinoma (OSCC) or adenocarcinoma (OAC) after chemoradiotherapy, with 95% of participants successfully completing the procedure and 90% of samples suitable for biomarker analysis.

The study found that the Cytosponge™ results were largely concordant with standard endoscopic biopsies, suggesting it could be a viable alternative for monitoring residual disease, although some discrepancies were noted that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a non-endoscopic immunocytological device (Cytosponge™) for post chemoradiotherapy surveillance in patients with oesophageal cancer in the UK (CYTOFLOC): A multicentre feasibility study. Jones, CM., O'Connor, H., O'Donovan, M., 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]

Over 90% of patients with epidermoid carcinoma of the esophagus develop advanced, incurable disease within five years, making palliative care the primary focus, with various surgical options available to improve swallowing function.

Newer investigational chemotherapy combinations, such as cisplatin, vindesine, and bleomycin, have shown promising results, inducing major regressions in 50% of patients and achieving resection rates of 75-85% in those with locoregional disease after preoperative therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of advanced esophageal cancer. Kelsen, D.[2004]

Citations

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

Biomarker risk stratification with capsule sponge in the ... As earlier detection (stage T2 or less) vastly improves outcomes in oesophageal adenocarcinoma, patients with the precursor lesion, Barrett's oesophagus, are ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11590222/

Clinical application of capsule sponge testing in ... This prospective cohort study presents the first real-world results and evaluates the clinical application of capsule sponge testing in symptomatic reflux ...

3. healio.com healio.com/news/gastroenterology/20250710/capsulesponge-test-could-replace-endoscopy-in-surveillance-of-lowrisk-barretts-esophagus

Capsule sponge stratifies cancer risk in Barrett's esophagus A capsule-sponge test may help identify patients with Barrett's esophagus who are at low risk for dysplasia or esophageal cancer and potentially eliminate the ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03961945

Study Details | NCT03961945 | Minimally Invasive ... This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection ...

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30099104/

Safety and Acceptability of Esophageal Cytosponge ... - PubMed The Cytosponge test is a safe procedure with good acceptability ratings in a variety of health care settings.

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

Cytosponge®: a systematic review of multi-center data Cytosponge is a novel, minimally invasive esophageal cell collection device. We aimed to assess the data on safety and acceptability of this device.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1542356518308097

Safety and Acceptability of Esophageal Cytosponge Cell ... This technical review of 5 large prospective studies on the performance of the Cytosponge showed that it is a safe procedure with good acceptability ratings.