Nitrates and IL-8 in Barrett's Esophagus

Sponsor

Mayo Clinic (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04642690

Collaborator

(none)

Enrollment

Location

45.2

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Barrett Esophagus Esophageal Adenocarcinoma

Study Design

Study Type:

Observational

Anticipated 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 :

Sep 24, 2020

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Primary Outcome Measures

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 Outcome Measures

Biomarkers and disease progression [Baseline]
Level of IL-8 in serum and tissue in patients with NDBE that progressed to BE

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Kenneth Wang, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Kenneth K. Wang, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT04642690

Other Study ID Numbers:

20-004618

First Posted:

Nov 24, 2020

Last Update Posted:

Apr 8, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenocarcinoma

Barrett Esophagus

Esophageal Neoplasms

Study Results

No Results Posted as of Apr 8, 2022