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.
Optional Additional Specimen Collection BEECAB participants who undergo ablative therapy
will be followed to see whether they achieve CE-IM and those who achieve CE-IM will be
followed to detect recurrent intestinal metaplasia and neoplasia (LGD, HGD or EAC) within
Barrett's esophagus. Optional additional cytology brushings and biopsy samples will be
collected for future investigations from participants undergoing any form of EET and with
low grade dysplasia (LGD), high grade dysplasia (HGD), or intramucosal or T1a cancer and
BE length > 1 cm. Those who had prior oncologic therapy with chemotherapy or radiation
for esophageal cancer and have depth of cancer > T1a or metastatic disease will not be
approached for additional samples.
Up to three research cytology brushings and 7 research forceps biopsy samples will be
collected during their standard of care EGD for this optional specimen collection.
a) Patients with HGD, LGD, or ECA undergoing Endoscopic Therapy for the first time
(initial EGD).
One cytology brushing from squamous tissue in the esophagus
Two cytology brushings from Barrett's Esophagus tissue
Up to five forceps biopsies from Barrett's Esophagus tissue
Up to two forceps biopsies from squamous tissue in the esophagus
b) Patients who have had prior ablation.
Up to two cytology brushings from neosquamous tissue in the esophagus post ablation
Up to two forceps biopsies from neosquamous tissue in the esophagus post ablation
Up to two forceps biopsies from squamous tissue in the esophagus
Up to two forceps biopsies from gastric fold
