Nitrates and IL-8 in Barrett's Esophagus
Terminated
- Conditions
- Esophageal AdenocarcinomaBarrett Esophagus
- Registration Number
- NCT04642690
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The purpose of this study is to determine if nitrates and IL-8 (which are found in food and throughout the body regulating stomach acidity) play a role in Barrett's Esophagus and/or Esophageal Adenocarcinoma severity and if screening for these biomarkers can help predict patients that are more at risk for developing worsening disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
- Patients undergoing a clinicallly-indicated Esophagogastroduoedoscopy (EGD).
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Exclusion Criteria
- Comorbid inflammatory medical condition.
- Use of antiinflammatory (aspirin and NSAIDs) or immunosuppressants over the past 1 week.
- Use of nitrate containing medication in the past 1 week.
- Consumption of nitrate rich foods in preceding 24 hours.
- Known allergy to meat or nitrates
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum and Tissue Biomarkers Baseline Levels of IL-8 in patients diagnosed BE dysplasia and EAC
Nitrate Levels Baseline Nitrate levels in serum, saliva and tissue in patients with normal squamous epithelium, erosive esophagitis, non-dysplastic BE (NDBE), and BE with high-grade dysplasia (HGD) or EAC
- Secondary Outcome Measures
Name Time Method Biomarkers and disease progression Baseline Level of IL-8 in serum and tissue in patients with NDBE that progressed to BE
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States