1350 Participants Needed

Sponge Capsule Diagnosis for Esophageal Cancer

Recruiting at 6 trial locations
EE
RL
CT
Overseen ByClinical Trials Referral Office
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.12345

How 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.678910

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.

Research Team

PG

Prasad G Iyer, MD

Principal Investigator

Mayo Clinic

Eligibility 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.

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

Treatment Details

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.
Participant Groups
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

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+

Findings from Research

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.
[Surgical treatment and prognostic analysis of 109 patients with primary esophageal small cell carcinoma].Zhang, BH., Yang, WJ., Zhao, L., et al.[2018]
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.
[Endotube insertion for palliation of esophageal and cardia cancer: experiences with a new endoprosthesis].Van Maercke, P., Schellong, H.[2009]
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.
Treatment of advanced esophageal cancer.Kelsen, D.[2004]

References

[Surgical treatment and prognostic analysis of 109 patients with primary esophageal small cell carcinoma]. [2018]
[Endotube insertion for palliation of esophageal and cardia cancer: experiences with a new endoprosthesis]. [2009]
Treatment of advanced esophageal cancer. [2004]
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]
[Palliative options for esophageal carcinoma]. [2018]
[Diagnosis of cancer of the esophagus by sponge smears (II)]. [2007]
Safety and efficacy of a minimally invasive cell sampling device ('Cytosponge') in the diagnosis of esophageal pathology: a systematic review. [2019]
Safety and Acceptability of Esophageal Cytosponge Cell Collection Device in a Pooled Analysis of Data From Individual Patients. [2021]
Sponge Sampling with Fluorescent In Situ Hybridization as a Screening Tool for the Early Detection of Esophageal Cancer. [2022]
Esophageal cytology sponge diagnostic test results in kenyatta national referral hospital, kenya. [2014]
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