CClinicalTrials.gg
Enrolling by invitationNCT07212491Updated Sep 29, 2026

Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma

An observational study in Barrett Esophagus and Esophageal Adenocarcinoma, sponsored by Mayo Clinic. Enrolling by invitation at 5 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
450
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Barrett Esophagus
  • Esophageal Adenocarcinoma
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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).

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

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 [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
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
450 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

    Other: Non-Interventional Study

Interventions

  • OtherNon-Interventional Study

    Non-interventional study

    Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study

05

What researchers measure

Primary outcomes

  1. Sensitivity of deoxyribonucleic acid (DNA) markers

    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).

    Time frame: Baseline

  2. Specificity of DNA markers

    Will evaluate the specificity of DNA markers (methylated DNA markers ± aneuploidy) to distinguish between HGD/EAC and non-dysplastic BE.

    Time frame: Baseline

06

Study locations

5 sites
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
  • Baylor Scott & White Research Institute
    Dallas, Texas 75204, United States
07

References and documents

08

Registry details

Key details

Study ID
NCT07212491
Lead sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 8, 2025
Start date
Nov 17, 2025
Primary completion
Jul 31, 2030 (estimated)
Completion
Jul 31, 2030 (estimated)
Last update
Sep 29, 2026

Study contacts

Prasad G. Iyer, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion