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Nitrates and IL-8 in Barrett's Esophagus

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ClinicalTrials.gov Identifier: NCT04642690
Recruitment Status : Enrolling by invitation
First Posted : November 24, 2020
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
David A. Katzka, Mayo Clinic

Study Description
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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.

Condition or disease
Barrett Esophagus Esophageal Adenocarcinoma

Study Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Association Between Nitrates, Nitrosylated Proteins, and Interleukin-8 in Barrett's Esophagus and Esophageal Adenocarcinoma
Actual Study Start Date : September 24, 2020
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Group 1-NSE
Patients found to have grossly normal squamous epithelium during endoscopy
Group 2-EEG
Patients found to have grossly apparent erosive esophagitis >1cm with Los Angeles Classification A-D
Group 3-NDBE Short
Patients with non-dysplastic Barrett's Esophagus (NDBE) > 1cm (Short Segment)
Group 4-NDBE Long
Patients with non-dysplastic Barrett's Esophagus (NDBE) > 1cm (Long Segment)
Group 5
Barrett's Esophagus (BE) with high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC)
Group 6-Esophagectomy
Patients undergoing resection of esophageal cancer
Group -7 Pilot and Feasibility
Patients undergoing EGD with NSE, NDBE, BE-HGD, or EAC for feasibility of analytical techniques


Outcome Measures
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Primary Outcome Measures :
  1. Nitrate Levels [ Time Frame: 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

  2. Serum and Tissue Biomarkers [ Time Frame: Baseline ]
    Levels of IL-8 in patients diagnosed BE dysplasia and EAC


Secondary Outcome Measures :
  1. Biomarkers and disease progression [ Time Frame: Baseline ]
    Level of IL-8 in serum and tissue in patients with NDBE that progressed to BE


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult individuals scheduled for clinically indicated EGD procedure. Subjects with normal squamous epithelium, erosive esophagitis, or varying degrees of Barrett's Esophagus may be enrolled.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642690


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: David A Katzka, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: David A. Katzka, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04642690    
Other Study ID Numbers: 20-004618
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Barrett Esophagus
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Precancerous Conditions
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms