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Enrolling By Invitation
NCT02427269
University of North Carolina (UNC) Barrett's Esophagus and Esophageal Cancer Biorepository
Conditions: Barrett's Esophagus, Esophageal Cancer, Intramucosal Adenocarcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1000
Sponsor: University of North Carolina, Chapel Hill
Location: UNC Chapel Hill Chapel Hill North Carolina
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.
Eligibility Criteria
Inclusion Criteria:
* Male or female aged 18 and older.
* Able to read, comprehend, and complete the informed consent form.
* Presenting to UNC hospitals for routine care upper endoscopy for their condition.
* Meet one of the following:
1. Current or previous diagnosis of Barrett's Esophagus (BE) with or without dysplasia OR
2. Current or previous diagnosis of esophageal cancer (including esophageal adenocarcinoma, intramucosal carcinoma, and squamous cell carcinoma)
* Willing to undergo biopsy and blood collection for research purposes.
Exclusion Criteria:
* Unable to read or understand English.
* Current incarceration.
* Current use of blood thinners such as coumadin, warfarin, clopidogrel, heparin and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 6 days after esophagogastroduodenoscopy \[EGD\] and/or ensuring blood thinners have been stopped within an appropriate time frame for that specific agent and in accordance with standard clinical practice).
* Known bleeding disorder.
Source: ClinicalTrials.gov (NCT02427269). StuddyBuddy aggregates publicly available trial information.