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ENROLLING BY INVITATION
NCT02427269

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

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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.

Official title: UNC Barrett's Esophagus and Esophageal Cancer Biorepository

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2015-04-28

Completion Date

2028-05

Last Updated

2025-05-29

Healthy Volunteers

No

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.

Locations (1)

UNC Chapel Hill

Chapel Hill, North Carolina, United States