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NCT04642690 Clinical Trial

Nitrates and IL-8 in Barrett's Esophagus

Barrett Esophagus Clinical Trial

Official title:
The Association Between Nitrates, Nitrosylated Proteins, and Interleukin-8 in Barrett's Esophagus and Esophageal Adenocarcinoma

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04642690
Other study ID # 20-004618
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 24, 2020
Est. completion date December 9, 2022

Study information
Verified date December 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 9
Est. completion date December 9, 2022
Est. primary completion date December 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients undergoing a clinicallly-indicated Esophagogastroduoedoscopy (EGD). 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Nitrate Levels 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 Baseline
Primary Serum and Tissue Biomarkers Levels of IL-8 in patients diagnosed BE dysplasia and EAC Baseline
Secondary Biomarkers and disease progression Level of IL-8 in serum and tissue in patients with NDBE that progressed to BE Baseline
See also
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Completed NCT02560623 - A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus N/A
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Recruiting NCT04001478 - Non-invasive Testing for Early oEesophageal Cancer and Dysplasia
Completed NCT03859557 - The Evaluation of Patients With Esophageal and Foregut Disorders With WATS (Wide Area Transepithelial Sample With 3-Dimensional Computer-Assisted Analysis) vs. 4-Quadrant Forceps Biopsy
Completed NCT04587310 - Does Laparoscopic Sleeve Gastrectomy Lead to Barrett's Esophagus, 5-year Esophagogastroduodenoscopy Findings: A Retrospective Cohort Study
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