Barrett Esophagus, Esophageal Adenocarcinoma
Conditions
Brief summary
This study explores the use of a minimally invasive screening tool (a sponge on a string device) to detect Barrett's esophagus and esophageal adenocarcinoma and to develop a laboratory test for the detection of Barrett's esophagus-high grade dysplasia and esophageal adenocarcinoma.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
Mayo Clinic
National Cancer Institute (NCI)
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patient between the ages 18 - 90 * Patients with a BE segment \>= 1cm in maximal extent endoscopically * Histology showing evidence of intestinal metaplasia with or without presence of dysplasia * Undergoing clinically indicated endoscopy
Exclusion criteria
* Patients with a prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with a history of endoscopic mucosal resection alone will not be excluded * Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma * Subjects with known evidence of BE (on history or review of medical records) * Pregnant or lactating females * Patients who are unable to consent * Patients with a current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study for RST/ARZ sites only) * History of eosinophilic esophagitis or achalasia * Patients on oral anticoagulation including Coumadin, and warfarin, unless discontinued for thee to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only) * Patients on antiplatelet agents including clopidogrel, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only) * Patients on oral thrombin inhibitors including dabigatran and oral factor X an inhibitor such as rivaroxaban, apixaban, and edoxaban, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only) * Patients with a history of known esophageal or gastric varices or cirrhosis * Patients with a history of esophageal or gastric resection * 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 * Patients with Familial Adenomatous Polyposis (FAP) or Lynch Syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of DNA markers | Baseline | Will evaluate the specificity of DNA markers (methylated DNA markers ± aneuploidy) to distinguish between HGD/EAC and non-dysplastic BE. |
| Sensitivity of deoxyribonucleic acid (DNA) markers | Baseline | Will evaluate the sensitivity of DNA makers (methylated DNA markers ± aneuploidy) to distinguish between high-grade dysplasia (HGD)/esophageal adenocarcinoma (EAC) and non-dysplastic Barrett's esophagus (BE). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPrasad G. Iyer, MD
Mayo Clinic
Outcome results
None listed