Nitrates and IL-8 in Barrett's Esophagus

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04642690

Enrollment

Registered

2020-11-24

Start date

2020-09-24

Completion date

2022-12-09

Last updated

2022-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett Esophagus, Esophageal Adenocarcinoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Nitrate Levels	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
Serum and Tissue Biomarkers	Baseline	Levels of IL-8 in patients diagnosed BE dysplasia and EAC

Secondary

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

Countries

United States

Outcome results