Nitrates and IL-8 in Barrett's Esophagus

NCT ID: NCT04642690

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-24

Study Completion Date

2022-12-09

Brief Summary

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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

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Conditions

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Barrett Esophagus Esophageal Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1-NSE

Patients found to have grossly normal squamous epithelium during endoscopy

No interventions assigned to this group

Group 2-EEG

Patients found to have grossly apparent erosive esophagitis \>1cm with Los Angeles Classification A-D

No interventions assigned to this group

Group 3-NDBE Short

Patients with non-dysplastic Barrett's Esophagus (NDBE) \> 1cm (Short Segment)

No interventions assigned to this group

Group 4-NDBE Long

Patients with non-dysplastic Barrett's Esophagus (NDBE) \> 1cm (Long Segment)

No interventions assigned to this group

Group 5

Barrett's Esophagus (BE) with high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC)

No interventions assigned to this group

Group 6-Esophagectomy

Patients undergoing resection of esophageal cancer

No interventions assigned to this group

Group -7 Pilot and Feasibility

Patients undergoing EGD with NSE, NDBE, BE-HGD, or EAC for feasibility of analytical techniques

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Cadman Leggett

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cadman Leggett, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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20-004618

Identifier Type: -

Identifier Source: org_study_id