ClinicalTrials.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

Updated Sep 29, 2026Eligibility revised2 sites addedGo to Updates ↓

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

Where this study stands

Counted across the records on this site · 2026-11-15

Among 40 studies in Barrett Esophagus by Mayo Clinic — 6 open to participants now, 6 under way, none of them phase 3. Barrett Esophagus · Mayo Clinic.

Planned enrollment
4th of 21
450 · median 90
Started
2025
with 2 others
Observational
21 of 40
3 open now
Registered
40th of 40
by date

Among the 40 studies in Barrett Esophagus by Mayo Clinic, this one is the 4th largest by planned enrollment of the 21 observational ones that give a count, is one of 3 that started in 2025, is one of 21 observational ones, and was the 40th registered.

Barrett Esophagus

312 studies on the registry are indexed under Barrett Esophagus; 60 are open to participants now.

Browse Barrett Esophagus studies →

Open to participants now

6 of the 40 studies in Barrett Esophagus by Mayo Clinic are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 44 Barrett Esophagus studies recruiting now, 31 (70%) set no upper age limit and 2 (5%) stop at 75 or younger; 4 take children under 18; 10 take healthy volunteers.

This study: 18 Years to 90 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

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.

03

Conditions studied

  • Barrett Esophagus
  • Esophageal Adenocarcinoma
04

Who can participate

The criteria were revised on the registry on Sep 29, 2026. See what changed

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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser 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/ 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

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

06

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

07

Study locations

5 sites
08

References and documents

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Jul 2030, 56 months after the start.

Of 40 observational studies under Barrett Esophagus, half reached primary completion within 252 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 252. This study's planned 56 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 30, 2025
First posted
Oct 8, 2025
StartActual
Nov 17, 2025
Primary completionEst.
Jul 31, 2030
CompletionEst.
Jul 31, 2030
Last update
Sep 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites added
Show 2 added (2 United States)
  • University of Rochester Medical Center · Rochester, United States
  • Baylor Scott & White Research Institute · Dallas, United States
Sep 29, 2026
Eligibility
1 exclusion criterion edited
What changed in the criteria
Exclusion criteria
  • EditedPatients with a current history of uninvestigated dysphagia (this [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)]
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    2 sites added
    Show 2 added (2 United States)
    • University of Rochester Medical Center · Rochester, United States
    • Baylor Scott & White Research Institute · Dallas, United States
    Eligibility 1 exclusion criterion edited
    What changed in the criteria
    Exclusion criteria
    • EditedPatients with a current history of uninvestigated dysphagia (this [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)]
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07212491
Lead sponsor
Mayo Clinic
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 ↗

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