Swallowed sponge test to find Barrett esophagus and esophageal cancer
Tests a swallowed sponge for spotting Barrett esophagus and esophageal cancer.
Key facts
- Who runs it
- Mayo Clinic
- Where
- Dallas, Jacksonville, Rochester, and Scottsdale, United StatesSee the 5 sites
- Trial code
- Registry title
- Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma
- Status
- Enrolling by invitation
- People taking part
- 450 people, planned
- Started
- 17 Nov 2025
- Expected to end
- 31 Jul 2030
- Type of study
- Observational
- Treatments tested
- Non-Interventional Study
- Record updated
- 29 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Barrett's esophagus who are having an endoscopy their doctor already planned. It tests a swallowed sponge-on-a-string device and a lab test.
- Age
- 18 to 90 years
- Sex
- All sexes
- Disease stage
- Barrett's esophagus segment of 1cm (0.4 in) or more at endoscopy, with intestinal metaplasia (changed lining cells) with or without dysplasia (abnormal cells).
- Earlier treatment
- No prior ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Endoscopic mucosal resection alone is allowed. No chemotherapy or radiation for mediastinal or esophageal cancer.
- Biomarker or test result
- Tissue sample showing intestinal metaplasia.
Main reasons for not taking part
- Past surgery removing part of the esophagus or stomach
- Varices or cirrhosis, or a bleeding disorder
- Eosinophilic esophagitis, achalasia, or unexplained trouble swallowing
- Blood thinners or antiplatelet drugs not stopped 3 to 5 days before the sponge test
- Pregnant or breastfeeding, FAP or Lynch Syndrome, or foregut cancer within 5 years
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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 [does not apply to the brushings/biopsies only portion of the study for Mayo Clinic in Rochester (RST)/Mayo Clinic in Arizona (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
- Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Where in United States
- Baylor Scott & White Research InstituteDallas, United StatesEnrolling by invitation
- Mayo Clinic in FloridaJacksonville, United StatesEnrolling by invitation
- Mayo Clinic in RochesterRochester, United StatesEnrolling by invitation
- University of Rochester Medical CenterRochester, United StatesEnrolling by invitation
- Mayo Clinic in ArizonaScottsdale, United StatesEnrolling by invitation
About the trial
What the trial wants to find out
This study explores the use of a minimally invasive screening tool (a sponge on a string device) to detect Barrett's esophagus and esophageal adenocarcinoma and to develop a laboratory test for the detection of Barrett's esophagus-high grade dysplasia and esophageal adenocarcinoma.
The group in the trial
- Observational
Patients undergo capsule sponge assessment over 5-10 minutes prior to standard of care endoscopy. Patients also undergo biopsy and esophageal brushing sample collection and complete questionnaires on study.
Treatment: Non-Interventional Study
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma- Renewal Grant Aim 2 (The SOS6C Trial)
- Plain-language title
- Swallowed sponge test to find Barrett esophagus and esophageal cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07212491, who can take part
- Record updated
- 29 September 2026