Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
Recruiting
N/AInterventional Study
Barrett EsophagusEsophageal Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 90
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
1,550 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.