Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
3 other identifiers
interventional
1,550
1 country
9
Brief Summary
This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2019
CompletedFirst Posted
Study publicly available on registry
May 23, 2019
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2030
January 26, 2026
January 1, 2026
9.1 years
May 15, 2019
January 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Aim 1 - Screening Population
To measure the positive and negative predictive value of the sponge capsule Barrett's esophagus test in a screening population.
5 years
Aim 2 - Case/Control Population BE Detection
Compare the sensitivity and specificity of a predetermined BE prediction algorithm for those with and without GERD and assess the influence of other covariates (age, sex, ever smoking, ethnicity and BMI) on this algorithm.
5 years
Aim 3 - Dysplasia Detection Sensitivity and Specificity
Measure the sensitivity and specificity of a predetermined MDM panel assayed on SOS specimens from BE patients identified in Aims 1 and 2, for the detection of HGD /EAC, using surveillance histology as the criterion standard.
5 years
Secondary Outcomes (4)
Aim 1 - Screening Population Predictive Value
5 years
Aim 1 - Screening Population Safety and Tolerability of sponge capsule procedure
5 years
Aim 2 - Case/Control Population Sensitivity and Specificity
5 years
Aim 3 - Dysplasia Detection Rate of Missed Dysplasia
5 years
Study Arms (3)
Screening Population
OTHERThose that have gastroesophageal reflux or other risk factors for Barrett's Esophagus will be contacted and if agreeable undergo sponge capsule procedure and fill out questionnaires.
Upper endoscopy - Barrett's Esophagus
OTHERThose that have a diagnosis of Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.
Upper endoscopy - No Barrett's Esophagus
OTHERThose that have no known Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.
Interventions
Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.
Eligibility Criteria
You may qualify if:
- Male and female ages 50-85
- Patients who have three or more risk factors for Barrett's Esophagus.
- Gastroesophageal reflux disease defined by:
- Diagnosis
- Use of one of the following drugs \>= 3 months over the last 5 years: omeprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole, lansoprazole, ranitidine, famotidine, cimetidine
- prior endoscopic diagnosis of erosive esophagitis
- Body mass index (BMI) \>= 30
You may not qualify if:
- Previous history of:
- esophageal adenocarcinoma/cancer
- esophageal squamous carcinoma
- endoscopic ablation for Barrett's esophagus
- esophageal squamous dysplasia
- Current treatment with oral anticoagulation including Warfarin, Coumadin
- History of cirrhosis
- History of esophageal/gastric varices
- History of Barrett's esophagus
- Prior endoscopy in the last 5 years
- Subjects with known or suspected BE (cases).
- Patient between the ages 18 - 90.
- Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
- Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
- Undergoing clinically indicated endoscopy.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Cancer Institute (NCI)collaborator
Study Sites (9)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Mayo Clinic Health Systems - Austin
Austin, Minnesota, 55912, United States
Mayo Clinic Health Systems - Mankato
Mankato, Minnesota, 56001, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Northwell Health
New Hyde Park, New York, 11040, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75246, United States
Mayo Clinic Health System-Eau Claire
Eau Claire, Wisconsin, 54701, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prasad G. Iyer, M.D.
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2019
First Posted
May 23, 2019
Study Start
July 1, 2021
Primary Completion (Estimated)
July 30, 2030
Study Completion (Estimated)
July 30, 2030
Last Updated
January 26, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share