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.
The sponge on a string (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 the SOS device to enable detection in Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,550
Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.
Mayo Clinic Arizona
Scottsdale, Arizona, United States
COMPLETEDMayo Clinic Jacksonville
Jacksonville, Florida, United States
COMPLETEDMayo Clinic Health Systems - Austin
Austin, Minnesota, United States
Aim 1 - Screening Population
To measure the positive and negative predictive value of the sponge capsule Barrett's esophagus test in a screening population.
Time frame: 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.
Time frame: 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.
Time frame: 5 years
Aim 1 - Screening Population Predictive Value
Compare positive predictive value and negative predictive value of the sponge capsule Barrett's Esophagus test between those with and without chronic GERD.
Time frame: 5 years
Aim 1 - Screening Population Safety and Tolerability of sponge capsule procedure
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).
Time frame: 5 years
Aim 2 - Case/Control Population Sensitivity and Specificity
Validate specificity and sensitivity cut offs of a BE prediction algorithm in an independent patient cohort
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Mayo Clinic Health Systems - Mankato
Mankato, Minnesota, United States
COMPLETEDMayo Clinic Rochester
Rochester, Minnesota, United States
RECRUITINGNorthwell Health
New Hyde Park, New York, United States
COMPLETEDBaylor Scott & White Research Institute
Dallas, Texas, United States
COMPLETEDMayo Clinic Health System-Eau Claire
Eau Claire, Wisconsin, United States
RECRUITINGMayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States
WITHDRAWNTime frame: 5 years
Aim 3 - Dysplasia Detection Rate of Missed Dysplasia
Measure diagnostic uncertainty bias in the criterion standard, specifically, the rate of dysplasia missed by surveillance histology
Time frame: 5 years