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

• ClinicalTrials.gov Identifier: NCT02427269
• Recruitment Status: Enrolling by invitation
• First Posted: April 27, 2015
• Last Update Posted: March 22, 2023
• Sponsor: University of North Carolina, Chapel Hill
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

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.

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

Detailed Description:

Patients will be identified during GI clinic visits or procedure visits with Dr. Nicholas Shaheen or his colleagues at UNC. Patients may also be identified by research personnel during review of the endoscopy schedule and medical records. If eligible, interested participants will be provided with a consent form during their clinic or procedure visit. Enrolled subjects will be assigned a unique identification (ID) number for data collection.

Patients will be recruited by Dr. Nicholas Shaheen and his colleagues or by other study personnel prior to their routine care endoscopy at UNC. An investigator, study coordinator, or other personnel trained in the protocol and referenced in the IRB application will obtain consent during the patient's visit in the GI clinic or prior to an upper endoscopy. Potential subjects will have an opportunity to carefully review the consent form, the details of the study will be reviewed verbally, and all questions will be answered to the satisfaction of the patient. Only English-speaking adults with the ability to consent will be eligible for enrollment in this study. After the subject signs the consent, a copy of the signed consent will be provided to the subject and the coordinator will collect demographic and historical information from the patient pertaining to illnesses, medication and other relevant information. The consent process will be documented in the subject's research file.

After obtaining informed consent, blood will be obtained and subjects will proceed with their routine care upper endoscopy. The endoscopist, as per routine practice, will note findings in the procedure report and photograph or record video to confirm and document key findings, as well as take biopsies as indicated for routine care. During the procedure up to 10 research biopsies will be collected as part of this study. Research biopsies will be collected in addition to routine care biopsies and will be obtained with a standardized biopsy protocol (below). The total number of research biopsies may vary based on presence/absence of nodularity but will not exceed 10 research-specific biopsies. This number of esophageal biopsies is within the standard of care for biopsying the esophagus.

Biopsies for clinical care are taken prior to any consideration of research biopsies. Research biopsies are taken only if the additional biopsies do not significantly increase the patient's risk or interfere with routine care procedures. The research biopsy protocol may be modified by the physician performing the procedure if necessary.

In addition to research blood and biopsies, up to 4 cytology brushings for research purposes may also be obtained during the procedure.

Specimens collected for this research study will include:

• 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 esophagogastroduodenoscopy (EGD).

  • Four biopsies will be taken from the midpoint of the current Barrett's Esophagus (BE) (or midpoint of previous Barrett's Esophagus (BE) if the patient has already received ablation for previous Barrett's Esophagus (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 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

Biopsies will be immediately frozen on liquid nitrogen then transferred to the -80 biorepository freezer for long term storage. Blood will be immediately processed and transferred to the -80 biorepository freezer for long-term storage.

The translational pathology lab (TPL) maintains formalin fixed paraffin embedded (FFPE) blocks from biopsies taken for routine care. Slides will be cut from these blocks for this study. Slide requests for this research study will not exhaust the archived tissue and will leave a substantial amount of the formalin fixed paraffin embedded (FFPE) block for potential future clinical use.

If subjects return for additional esophagogastroduodenoscopies (EGDs) as part of routine care, then all study procedures will be repeated as part of this registry as detailed below.

For subjects receiving routine care surveillance esophagogastroduodenoscopy (EGD) for current or previous Barrett's Esophagus (BE) or current or previous esophageal cancer (ECA): Specimens and data will be collected at each routine care surveillance EGD as part of this study.

For subjects receiving routine care treatment EGD for current BE/ECA: Specimens and data will be collected at the initial treatment EGD, but not during subsequent treatment EGDs. Once treatment is complete and BE or ECA is clear, this group will begin surveillance EGDs as part of routine care for their condition. Specimens and data will be collected during subsequent follow-up surveillance EGDs after treatment is complete.

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, North Carolina

UNC Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: Nicholas Shaheen, MD, MPH; UNC Chapel Hill

More Information

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT02427269
• Other Study ID Numbers: 15-0444
• First Posted: April 27, 2015
• Last Update Posted: March 22, 2023
• Last Verified: March 2023

• 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:

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