Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
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 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.
Arms & interventions
- DeviceSponge Capsule
Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.
Outcome measures
Primary
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
Secondary
Aim 1 - Screening Population Predictive Value
Time frame: 5 years
Aim 1 - Screening Population Safety and Tolerability of sponge capsule procedure
Time frame: 5 years
Aim 2 - Case/Control Population Sensitivity and Specificity
Time frame: 5 years
Aim 3 - Dysplasia Detection Rate of Missed Dysplasia
Time frame: 5 years
Eligibility criteria
Study locations (9)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Mayo Clinic Health Systems - Austin
Austin, Minnesota, 55912
Mayo Clinic Health Systems - Mankato
Mankato, Minnesota, 56001
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Northwell Health
New Hyde Park, New York, 11040
Baylor Scott & White Research Institute
Dallas, Texas, 75246
Mayo Clinic Health System-Eau Claire
Eau Claire, Wisconsin, 54701
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601