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UNC Barrett's Esophagus and Esophageal Cancer Biorepository (BEECAB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02427269
Recruitment Status : Active, not recruiting
First Posted : April 27, 2015
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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 IRB approved studies that have a tissue and/or blood specimen component.


Condition or disease Intervention/treatment
Barrett's Esophagus Esophageal Cancer Intramucosal Adenocarcinoma Other: Specimen Collection

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: UNC Barrett's Esophagus and Esophageal Cancer Biorepository
Actual Study Start Date : April 28, 2015
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
  • 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) 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
  • 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
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
  • 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.

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
  • 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.

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
  • 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.




Primary Outcome Measures :
  1. Specimen Biorepository [ Time Frame: 10 years ]

    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.


  2. Data [ Time Frame: 10 years ]
    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.

  3. Collaboration with other investigators [ Time Frame: 10 years ]
    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.


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are receiving routine care upper endoscopy at UNC and meet the eligibility criteria detailed below.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427269


Locations
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United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Nicholas Shaheen, MD, MPH UNC Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02427269    
Other Study ID Numbers: 15-0444
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Barrett's Esophagus
Esophageal Cancer
Intramucosal Adenocarcinoma
Additional relevant MeSH terms:
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Adenocarcinoma
Esophageal Neoplasms
Barrett Esophagus
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Precancerous Conditions