NCT07212491
Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma
Enrolling by Invitation
Not specifiedAges 18–90ObservationalMayo ClinicInvestigator-initiated
~450 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Non-Interventional Study
At a glance
Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity of deoxyribonucleic acid (DNA) markers
Measured over Baseline
+1 more outcome measured
Conditions
Where it's being run
3 sites across 3 statesArizona1
Florida1
Minnesota1
Study leadership
- Prasad G. Iyer, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Sensitivity of deoxyribonucleic acid (DNA) markersBaseline
Will evaluate the sensitivity of DNA makers (methylated DNA markers ± aneuploidy) to distinguish between high-grade dysplasia (HGD)/esophageal adenocarcinoma (EAC) and non-dysplastic Barrett's esophagus (BE).
- Specificity of DNA markersBaseline
Will evaluate the specificity of DNA markers (methylated DNA markers ± aneuploidy) to distinguish between HGD/EAC and non-dysplastic BE.