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

Launched by MAYO CLINIC · May 22, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new device called a sponge capsule that can help find Barrett's Esophagus and related conditions like esophageal adenocarcinoma, which is a type of cancer. The trial will include participants who are being screened for these conditions, especially those with a history of chronic acid reflux, which can increase the risk of Barrett's Esophagus.

To be eligible, you should be between 50 and 85 years old and have at least three risk factors for Barrett's Esophagus. However, if you have a history of Barrett's Esophagus or esophageal cancer, or if you have had an endoscopy in the last five years, you would not qualify. Participants will undergo a simple procedure with the sponge capsule, which is designed to collect samples from the esophagus to help with diagnosis. This study aims to improve how we detect these serious conditions, ultimately leading to better patient care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria arm 1:
• • 1. Male and female ages 50-85
• • 2. Primary Care patients from Mayo Clinic Rochester or Mayo Clinic Health Systems.
• • 3. Patients who have three or more risk factors for Barrett's Esophagus.
• Exclusion Criteria arm 1:
• • 1. History of Barrett's esophagus or esophageal adenocarcinoma.
• • 2. Prior endoscopy in the last 5 years.
• • 3. Pregnant or lactating females.
• • 4. Patients who are unable to consent.
• • 5. Patients with current history of uninvestigated dysphagia
• • 6. History of eosinophilic esophagitis, achalasia.
• • 7. Patients on oral anticoagulation including Coumadin, Warfarin.
• • 8. Patients on antiplatelet agents including Clopidogrel (Visit 1), unless discontinued for three to five days prior to the sponge/endoscopy procedure (Visit 2 and 3).
• • 9. Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban (Visit 1), unless discontinued for three to five days prior to the sponge/endoscopy procedure (Visit 2 and 3).
• • 10. Patients with history of known esophageal/gastric varices or cirrhosis.
• • 11. Patients with history of esophageal resection due to carcinoma.
• • 12. Patients with congenital or acquired bleeding diatheses.
• • 13. Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma.
• • 14. Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
• • 15. Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.
• Inclusion criteria arm 2:
• • 1. Subjects with known or suspected BE (cases).
• • 1. Patient between the ages 18 - 90.
• • 2. Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
• • 3. Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
• • 4. Undergoing clinically indicated endoscopy.
• • 2. Subjects without known history of BE (controls). 1. Undergoing clinically indicated diagnostic endoscopy.
• Exclusion criteria arm 2:
• • 1. Subjects with known BE.
• • 1. 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.
• • 2. Patients with history of esophageal resection for esophageal carcinoma.
• 2. For subjects with or without known evidence of BE (on history or review of medical records):
• • 1. Pregnant or lactating females.
• • 2. Patients who are unable to consent.
• • 3. Patients with current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study).
• • 4. History of eosinophilic esophagitis, achalasia.
• • 5. Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings/biopsies only portion of the study).
• • 6. Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure.
• • 7. Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the sponge procedure.
• • 8. Patients with history of known esophageal or gastric varices or cirrhosis.
• • 9. Patients with history of surgical esophageal resection for esophageal carcinoma.
• • 10. Patients with congenital or acquired bleeding diatheses.
• • 11. Patients with a history of esophageal squamous dysplasia.
• • 12. Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
• • 13. Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.