Nitrates and IL-8 in Barrett's Esophagus

December 13, 2022 updated by: Cadman Leggett, Mayo Clinic

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

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
Serum and Tissue Biomarkers
Time Frame: Baseline
Levels of IL-8 in patients diagnosed BE dysplasia and EAC
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers and disease progression
Time Frame: Baseline
Level of IL-8 in serum and tissue in patients with NDBE that progressed to BE
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Cadman Leggett, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2020

Primary Completion (Actual)

December 9, 2022

Study Completion (Actual)

December 9, 2022

Study Registration Dates

First Submitted

October 9, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (Actual)

November 24, 2020

Study Record Updates

Last Update Posted (Actual)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-004618

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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