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

Overview

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

• Device Sponge Capsule
  Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.

Primary outcome measures

• Aim 1 - Screening Population [Time frame: 5 years]
• Aim 2 - Case/Control Population BE Detection [Time frame: 5 years]
• Aim 3 - Dysplasia Detection Sensitivity and Specificity [Time frame: 5 years]

Secondary outcome measures (4)

• 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

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.

Exclusion criteria Aim 2:

• Subjects with known BE.

• Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD) alone will not be excluded.
• Patients with history of esophageal resection for esophageal carcinoma.
• For subjects with or without known evidence of BE (on history or review of medical records):

• Pregnant or lactating females.
• Patients who are unable to consent.
• Patients with current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study).
• History of eosinophilic esophagitis, achalasia.
• Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings/biopsies only portion of the study).
• Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure.
• Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the sponge procedure.
• Patients with history of known esophageal or gastric varices or cirrhosis.
• Patients with history of surgical esophageal resection for esophageal carcinoma.
• Patients with congenital or acquired bleeding diatheses.
• Patients with a history of esophageal squamous dysplasia.
• Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
• Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 9 centers

• Mayo Clinic Arizona — Scottsdale
• Mayo Clinic Jacksonville — Jacksonville
• Mayo Clinic Health Systems - Austin — Austin
• Mayo Clinic Health Systems - Mankato — Mankato
• Mayo Clinic Rochester — Rochester
• Northwell Health — New Hyde Park
• Baylor Scott & White Research Institute — Dallas
• Mayo Clinic Health System-Eau Claire — Eau Claire
• … and 1 more center

Identifiers

NCT: NCT03961945 · 19-002629 · R01CA241164 · NCI-2021-14395

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗