What this study is
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.
What's being tested
- Specimen Collection
Intervention · OTHER
* 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.
Study details
- Official title
- UNC Barrett's Esophagus and Esophageal Cancer Biorepository
- Sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Barrett's Esophagus · Esophageal Cancer · Intramucosal Adenocarcinoma
- Enrolling
- 1,000 people
- Starts
- 2015-04-28
- Est. completion
- 2028-05
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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:; Current or previous diagnosis of Barrett's Esophagus (BE) with or without dysplasia OR; 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUNC Chapel Hill
Chapel Hill, North Carolina, United States
Study team
Sponsor
University of North Carolina, Chapel Hill
Study ID 15-0444
Principal investigator
Nicholas Shaheen, MD, MPH
UNC Chapel Hill
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.