Nitrates and IL-8 in Barrett's Esophagus

NCT04642690 | Terminated

• 1 other identifier: 20-004618
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett Esophagus; Esophageal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Nitrate Levels

  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

  Levels of IL-8 in patients diagnosed BE dysplasia and EAC

  Baseline

Secondary Outcomes (1)

• Biomarkers and disease progression

  Baseline

Study Arms (7)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Patients undergoing a clinicallly-indicated Esophagogastroduoedoscopy (EGD).

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Cadman Leggett, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: November 24, 2020
• Study Start: September 24, 2020
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)