Barrett Esophagus, Esophageal Adenocarcinoma
Conditions
Keywords
Barrett's Esophagus, Gastroesophageal Reflux, Reflux, Esophageal Cancer, Esophageal Adenocarcinoma
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 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.
Interventions
DEVICESponge Capsule
Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.
Sponsors
Mayo Clinic
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Aim1: * 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
Exclusion criteria
Aim1 and Aim 3: * 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 Inclusion criteria Aim 2 and Aim 3: * 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. * Subjects without known history of BE (controls). * Undergoing clinically indicated diagnostic endoscopy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORPrasad G. Iyer, M.D.
Mayo Clinic
Outcome results
None listed