Sponge Capsule Diagnosis for Esophageal Cancer
Recruiting in Palo Alto (17 mi)
+6 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: Barrett's esophagus, Dysphagia, Cirrhosis, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.
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 data supports the effectiveness of the treatment Sponge Capsule, Cytosponge, EndoSign, EsophaCap, EsoCheck for esophageal cancer?
The Cytosponge™ has been evaluated for safety, acceptability, and tolerability in monitoring treatment response in esophageal cancer patients after chemoradiotherapy, suggesting it may be a useful tool in assessing treatment outcomes.
12345How does the sponge capsule treatment for esophageal cancer differ from other treatments?
The sponge capsule treatment, known as the Cytosponge, is unique because it is a minimally invasive method that involves swallowing a capsule with a sponge inside. Once the capsule dissolves in the stomach, the sponge expands and collects cells from the esophagus as it is pulled out, offering a less expensive and more patient-friendly alternative to traditional endoscopic procedures.
678910Eligibility Criteria
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.
Trial Timeline
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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Group I: Upper endoscopy - No Barrett's EsophagusExperimental Treatment1 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 EsophagusExperimental Treatment1 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 PopulationExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic JacksonvilleJacksonville, FL
Mayo Clinic Health Systems - MankatoMankato, MN
Baylor Scott & White Research InstituteDallas, TX
Mayo Clinic Health System-Eau ClaireEau Claire, WI
More Trial Locations
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
[Surgical treatment and prognostic analysis of 109 patients with primary esophageal small cell carcinoma]. [2018]Since the principles of treatment of primary esophageal small cell carcinoma (PESCC) remain still in controversy, the aim of this study was to investigate the clinical characteristics, treatment modalities and prognostic factors of this malignancy.
[Endotube insertion for palliation of esophageal and cardia cancer: experiences with a new endoprosthesis]. [2009]Therapy of inoperable carcinoma of the esophagus and cardia must be based on correction of the dysphagia. On that purpose, a new endoprosthesis (type ESKA-Buess) was used. 57 patients were treated by endoscopic placement of an endoprosthesis. The mortality was 3.5%, patients survived appr. 3 months. All patients experienced a marked improvement in swallowing ability, 61% of our patients could swallow normally. The new endoprosthesis showed no relevant alteration in regard to form and material.
Treatment of advanced esophageal cancer. [2004]Over 90% of patients with epidermoid carcinoma of the esophagus will either present with or will develop advanced incurable disease within five years of diagnosis. The primary goal of therapy for these patients if palliation. A variety of surgical approaches have been used to restore or improve swallowing function. Gastrostomy tubes, dilation, or intraluminal tubes are the simplest procedures but do not usually allow use of a normal diet. More aggressive approaches involving bypass or palliative resection have a substantial morbidity and mortality but dietary intake is more normal. Radiation therapy, given in a palliative fashion, gives substantial relief from dysphagia in only 50% of patients, usually for a 2--6 month period. Although conventional chemotherapeutic agents are of little of no benefit, newer investigational drugs, used in combination, appear substantially more effective. The combination of cisplatin, vindesine, and bleomycin has been noted to induce major objective regressions in 50% of a group of 62 patients with either metastatic or locoregional disease. In patients with disease limited to the locoregional area, resection rates following preoperative therapy with cisplatin-based combination chemotherapy (with or without concommitant radiation) range from 75--85%. Whether the increased response rates seen with newer systemic agents will lead to improved disease-free and total survivals is not yet known.
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. [2023]Effective surveillance strategies are required for patients diagnosed with oesophageal squamous cell carcinoma (OSCC) or adenocarcinoma (OAC) for whom chemoradiotherapy (CRT) is used as a potentially-curative, organ-sparing, alternative to surgery. In this study, we evaluated the safety, acceptability and tolerability of a non-endoscopic immunocytological device (the Cytosponge™) to assess treatment response following CRT.
[Palliative options for esophageal carcinoma]. [2018]Considering the limited chances of radically curing esophageal carcinoma, most of these patients are candidates for palliative therapy. Priority should be given to rapid relief of dysphagia. Endoscopic implantation of esophageal prostheses is immediately effective in 90% of patients, whereas the onset of relief is slower with any alternative method. Long-term complications necessitate an endoscopic reintervention in 30% of the prosthesis carriers. Endoscopic prosthesis implantation is also the first-choice treatment for esophagotracheal fistulae. Self-expanding stents need only minimized preceding bougienage, which has lower complication rates than conventional plastic prostheses. Endoscopic laser radiation is better tolerated by patients than prosthesis implantation but is effective only in very short stenoses. Endoluminal brachytherapy with (192)iridium can be justified in patients with a survival expectancy of more than 6 months, the onset of its effect being slower but longer lasting. Palliative chemotherapy and radiochemotherapy are indicated when metastatic dissemination dominates the symptoms.
[Diagnosis of cancer of the esophagus by sponge smears (II)]. [2007]Forty-four patients with carcinoma of the esophagus, 21 with cancer of the gastric fundus with invasion of gastroesophageal junction, and 28 controls with non-tumoral esophageal problems were studied by the sponge smear technique, an effective procedure for cytologyc diagnosis of esophageal tumors. Several advantages of this technique over esophageal washings are described and its results are favorably compared with those obtained by esophageal washings.
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.
Safety and Acceptability of Esophageal Cytosponge Cell Collection Device in a Pooled Analysis of Data From Individual Patients. [2021]Diagnosis and surveillance of Barrett's esophagus (BE) and eosinophilic esophagitis (EoE) have become emerging public health issues. Cytosponge is a novel, minimally invasive esophageal cell collection device. We aimed to assess the data on safety and acceptability of this device.
Sponge Sampling with Fluorescent In Situ Hybridization as a Screening Tool for the Early Detection of Esophageal Cancer. [2022]Sponge cytology is a novel screening tool for esophageal cancer but has been unable to be validated for widespread use. Our aim was to apply fluorescent in situ hybridization to sponge cytology samples in order to evaluate the safety and efficacy of this modality in screening for esophageal cancer.
Esophageal cytology sponge diagnostic test results in kenyatta national referral hospital, kenya. [2014]To describe the cytological findings of the esophagus using sponge cytology as a triage test in patients referred for esophageal endoscopy at Kenyatta National Hospital.