Swallow a sponge to catch cancer early?
NCT ID NCT07212491
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a simple, less invasive way to detect Barrett's esophagus and esophageal cancer using a sponge on a string. Participants swallow the sponge, which collects cells from the esophagus. Researchers will analyze these cells to develop a lab test that can spot early signs of cancer. The goal is to make screening easier and more accessible for people at risk.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 450 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Consecutive patients with a history of confirmed BE, undergoing clinically indicated endoscopy at Mayo Clinic Rochester, Mayo Clinic Florida, Mayo Clinic Arizona, Baylor Dallas, and University of Rochester, NY. Participants who meet inclusion/exclusion criteria but decline to participate in the capsule sponge procedure will have the option to participate in the esophageal brushing/biopsies only portion of the study (this option applies to Rochester and Arizona site only).
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient between the ages 18 - 90 * Patients with a BE segment \>= 1cm in maximal extent endoscopically * Histology showing evidence of intestinal metaplasia with or without presence of dysplasia * Undergoing clinically indicated endoscopy Exclusion Criteria: * Patients with a prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with a history of endoscopic mucosal resection alone will not be excluded * Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma * Subjects with known evidence of BE (on history or review of medical records) * Pregnant or lactating females * Patients who are unable to consent * Patients with a current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study for RST/ARZ sites only) * History of eosinophilic esophagitis or achalasia * Patients on oral anticoagulation including Coumadin, and warfarin, unless discontinued for thee to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only) * Patients on antiplatelet agents including clopidogrel, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only) * Patients on oral thrombin inhibitors including dabigatran and oral factor X an inhibitor such as rivaroxaban, apixaban, and edoxaban, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only) * Patients with a history of known esophageal or gastric varices or cirrhosis * Patients with a history of esophageal or gastric resection * Patients with congenital or acquired bleeding diatheses * Patients with a history of esophageal squamous dysplasia * Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment * Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer * Patients with Familial Adenomatous Polyposis (FAP) or Lynch Syndrome
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
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Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- What do patients really want when facing oesophageal cancer surgery?
- Can a direct hit to tumors make immunotherapy work better?
- Can a new drug boost immunotherapy against Hard-to-Treat stomach cancer?
- Can a Pre-Surgery checklist predict who will still have reflux after fundoplication?
- New acid blocker may offer stronger reflux control for Barrett's esophagus