Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma

Not Applicable

Recruiting

• Conditions: Barrett Esophagus; Esophageal Adenocarcinoma
• Interventions: Device: Sponge Capsule

• Registration Number: NCT03961945
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

The SOS device will be safely administered by a non-physician such as a nurse. Novel discriminant methylated DNA markers will be assayed on esophageal cytology specimens obtained from a sponge on a string (SOS) device to enable detection in Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection.

Study Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-23
• Study Start: 2021-07-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-01-02
• Study Completion: 2027-01-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1350

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Upper endoscopy - No Barrett's Esophagus	Sponge Capsule	Those 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.
Screening Population	Sponge Capsule	Those 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	Sponge Capsule	Those 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.

Primary Outcome Measures

Name	Time	Method
Aim 3 - Dysplasia Detection Sensitivity and Specificity	5 years	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.
Aim 1 - Screening Population	5 years	To measure the positive and negative predictive value of the sponge capsule Barrett's esophagus test in a screening population.
Aim 2 - Case/Control Population BE Detection	5 years	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.

Secondary Outcome Measures

Name	Time	Method
Aim 2 - Case/Control Population Sensitivity and Specificity	5 years	Validate specificity and sensitivity cut offs of a BE prediction algorithm in an independent patient cohort
Aim 1 - Screening Population Safety and Tolerability of sponge capsule procedure	5 years	Safety and tolerability of the sponge capsule device in a screening population as measured by a Tolerability Questionnaire with sponge capsule procedure. Participants will rate their tolerability by rating questions using a scale of 0-10 (0 is none and 10 is severe or 0 is good and 10 is not good).
Aim 1 - Screening Population Predictive Value	5 years	Compare positive predictive value and negative predictive value of the sponge capsule Barrett's Esophagus test between those with and without chronic GERD.
Aim 3 - Dysplasia Detection Rate of Missed Dysplasia	5 years	Measure diagnostic uncertainty bias in the criterion standard, specifically, the rate of dysplasia missed by surveillance histology

Trial Locations

Locations (9)

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic Health Systems - Austin; 🇺🇸 Austin, Minnesota, United States

Mayo Clinic Health Systems - Mankato; 🇺🇸 Mankato, Minnesota, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

Northwell Health; 🇺🇸 New Hyde Park, New York, United States

Baylor Scott & White Research Institute; 🇺🇸 Dallas, Texas, United States

Mayo Clinic Health System-Eau Claire; 🇺🇸 Eau Claire, Wisconsin, United States

Mayo Clinic Health System-Franciscan Healthcare; 🇺🇸 La Crosse, Wisconsin, United States