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

NCT02427269 | Enrolling By Invitation

• 1 other identifier: 15-0444
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Barrett's Esophagus; Esophageal Cancer; Intramucosal Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• Specimen Biorepository

  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. To create a biorepository for future IRB approved studies that have a tissue and/or blood specimen component.

  10 years

• Data

  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.

  10 years

• Collaboration with other investigators

  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.

  10 years

Study Arms (5)

Barrett's Esophagus (BE) Surveillance

Patients who have never received ablative therapy for Barrett's Esophagus and are receiving routine care surveillance upper endoscopy for their condition. Subjects will have esophageal biopsies, blood, and data collected for this study.

Other: Specimen Collection

Barrett's Esophagus (BE) Pre-Ablation

Patients who are receiving routine care upper endoscopy with ablative therapy for their Barrett's Esophagus for the first time. Subjects will have esophageal biopsies, blood, and data collected for this study.

Other: Specimen Collection

Barrett's Esophagus (BE) Post-Ablation

Patients with a history of Barrett's Esophagus who are status post ablation and are receiving routine care follow-up EGD for their condition. Subjects will have esophageal biopsies, blood, and data collected for this study.

Other: Specimen Collection

Esophageal Cancer(ECA/IMC)

Patients with esophageal cancer who are receiving routine care upper endoscopy for their condition. Subjects will have esophageal biopsies, blood, and data collected for this study.

Other: Specimen Collection

Squamous Cell Carcinoma (SCC)

Patients with squamous cell cancer of the esophagus who are receiving routine care upper endoscopy for their condition. Subjects will have esophageal biopsies, blood, and data collected for this study.

Other: Specimen Collection

Interventions

Specimen Collection 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.

Barrett's Esophagus (BE) Post-Ablation; Barrett's Esophagus (BE) Pre-Ablation; Barrett's Esophagus (BE) Surveillance; Esophageal Cancer(ECA/IMC); Squamous Cell Carcinoma (SCC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are receiving routine care upper endoscopy at UNC and meet the eligibility criteria detailed below.

You 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 may not qualify 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

* 1 10mL red tube and 1 8.5mL yellow tube for serum, plasma, and buffy collection * Up to 10 research-specific biopsies (tissue samples) obtained from the esophagus during the routine care EGD. * Pathology slides from routine care biopsies taken during the 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

MeSH Terms

Conditions

Barrett Esophagus; Esophageal Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Nicholas Shaheen, MD, MPH

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 27, 2015
• Study Start: April 28, 2015
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

US (1)