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University of North Carolina (UNC) Barrett's Esophagus and Esophageal Cancer Biorepository

NCT02427269 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-05-29

No results posted yet for this study

Summary

Aim 1: To develop a prospective tissue and blood biorepository from patients with a history of Barrett's Esophagus (BE) or esophageal cancer (ECA) presenting to UNC hospitals for routine care upper endoscopy for their condition.

Aim 2: To collect clinical data from patients with a history of Barrett's Esophagus (BE) or esophageal cancer (ECA) that includes demographic data, endoscopic procedure data, and pathology data.

Aim 3: To integrate Aim 1 and 2 in a manner that will provide an efficient bi-directional flow of clinical information and specimens between laboratory and clinical scientists in order to foster innovative translational research.

Aim 4: To create a biorepository for future Institutional Review Board (IRB) approved studies that have tissue and/or blood specimen component.

Conditions

  • Barrett's Esophagus
  • Esophageal Cancer
  • Intramucosal Adenocarcinoma

Interventions

OTHER

Specimen Collection

* 1 10mL red tube and 1 8.5mL yellow tube for serum, plasma, and buffy collection * Up to 10 research-specific biopsies obtained from the esophagus during the routine care EGD. * Four biopsies will be taken from the midpoint of the current BE (or midpoint of previous BE if the patient has already received ablation for previous BE), * Two biopsies from normal squamous epithelium, and * One biopsy from each area of esophageal nodularity seen during the procedure * Pathology slides from routine care biopsies taken during the enrollment procedure, as well as retrospective pathology slides from routine care biopsies taken prior to enrollment on the study. * Up to 4 cytology brushes during the procedure.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Nicholas Shaheen, MD, MPH · UNC Chapel Hill

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-28
Primary Completion
2028-05-31
Completion
2028-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02427269 on ClinicalTrials.gov