Gastroesophageal Reflux Disease Clinical Trial
Official title:
Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition
Verified date | September 2023 |
Source | Dallas VA Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to elucidate mechanisms whereby oxidative stress induced by acute reflux esophagitis: 1) activates p38 to regulate proteins that control the G1/S cell cycle checkpoint, and 2) activates HIFs (hypoxia inducible factors) to cause autocrine VEGF (vascular endothelial growth factor) signaling that triggers the EMT (epithelial-mesenchymal-transition) program in Barrett's esophagus.
Status | Completed |
Enrollment | 15 |
Est. completion date | November 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - U.S. Veteran - Barrett's Esophagus Exclusion Criteria: - Inability to provide informed consent - Pregnancy or breastfeeding - Esophageal varices - Warfarin use - Coagulopathy that precludes safe biopsy of the esophagus - Comorbidity that precludes safe participation in the study |
Country | Name | City | State |
---|---|---|---|
United States | Dallas VA Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Dallas VA Medical Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in esophageal mucosal inflammation using histopathological assessment from baseline to 14 days | Inflammation of the esophageal mucosa will be measured at baseline, 7 days, and at 14 days. Esophageal mucosal inflammation will be measured using esophageal mucosal biopsy specimens, and histopatholgical grading. Mucosal infiltration with inflammatory cells (neutrophils, eosinophils, and lymphocytes) will be measured. | day 0, day 7, and day 14 | |
Secondary | change in p38 pathway from baseline to 14 days | p38 and components of the p38 pathway will be measured in the esophageal mucosa at baseline, 7 days, and at 14 days | day 0, day 7, and day 14 | |
Secondary | change in phosoho-p38 from baseline to 14 days | phospho-p38 will be measured in the esophageal mucosa at baseline, day 7, and at day 14 | day 0, day 7, and day 14 | |
Secondary | Show oxidative DNA damage associated with p38 activation | OxiSelect Oxidative DNA Damage ELISA assay of Barrett's mucosa at baseline, day 7, and day 14 | day 0, day 7, and day 14 | |
Secondary | change in VEGF from baseline to 14 days | VEGF will be measured in the esophageal mucosa at baseline, 7 days, and at day 14 | day 0, day 7, and day 14 | |
Secondary | change in APE-1 from baseline to 14 days | APE-1 will be measured in the esophageal mucosa at baseline, day 7, and at day 14 | day 0, day 7, and day 14 | |
Secondary | change in NPM1 from baseline to 14 days | NPM-1 will be measured in the esophageal mucosa at baseline, day 7, and at day 14 | day 0, day 7, and day 14 | |
Secondary | change in phospho-NPM1 from baseline to 14 days | phospho-NPM1 will be measured in the esophageal mucosa at baseline, day 7, and at day 14 | day 0, day 7, and day 14 | |
Secondary | change in miRNA expression from baseline to 14 days | miRNAs will be measured in the esophageal mucosa and in exosomes isolated from the blood at baseline, day 7, and day 14 | day 0, day 7, and day 14 | |
Secondary | change in HIF expression from baseline to 14 days | HIF expression will be measured in the esophageal mucosa at baseline, day 7, and day 14 | day 0, day 7, and day 14 |
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