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

Not Applicable

Recruiting

• Conditions: Barrett Esophagus; Esophageal Adenocarcinoma

• Registration Number: NCT03961945
• Lead Sponsor: Mayo Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-5-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aim 1 - Screening Population;Aim 2 - Case/Control Population BE Detection;Aim 3 - Dysplasia Detection Sensitivity and Specificity

Secondary Outcome Measures

Name	Time	Method
Aim 1 - Screening Population Predictive Value;Aim 1 - Screening Population Safety and Tolerability of sponge capsule procedure;Aim 2 - Case/Control Population Sensitivity and Specificity;Aim 3 - Dysplasia Detection Rate of Missed Dysplasia