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Nitrates and IL-8 in Barrett's Esophagus

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Mayo Clinic

Status

Terminated

Conditions

Barrett Esophagus
Esophageal Adenocarcinoma

Study type

Observational

Funder types

Other

Identifiers

NCT04642690
20-004618

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

9 participants in 7 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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