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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT02427269
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 28, 2015
Status verified
May 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Specimen Biorepository [ Time Frame: 10 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
UNC Chapel HillChapel HillNorth Carolina27599-

Find similar trials in Chapel Hill, NC

By condition
Esophageal cancer
By specialty
OncologyGI oncology
By research site
UNC Chapel Hill· Chapel Hill, NC

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