UNC Barrett's Esophagus and Esophageal Cancer Biorepository

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 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.

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.