Download Clinical Trials The University of Pennsylvania`s Division of

Clinical Trials
The University of Pennsylvania’s Division of Gastroenterology is internationally renowned and
has well recognized expertise in Barrett’s esophagus and esophageal cancer. We offer several
clinical trials with the aim to bring scientific discovery to patient care. If you would like to find
out additional information on enrollment in any of the studies below, we look forward to hearing
from you.
To discuss whether you are eligible to enroll in these studies
Contact: Maureen DeMarshall 215-349-8546 or [email protected]
Notch Signaling and Novel Biomarkers for Barrett’s Esophagus
BETRNet funded study (link to UPENN’s BETRNet)
Principal Investigators: Gary Falk, Gregory Ginsberg, John Lynch
Prospective cohort study of patients with BE, with or without associated dysplasia or
adenocarcinoma, and controls with and without GERD
This study hopes to identify new molecular markers in the tissue of Barrett's esophagus that will
help physicians better understand and manage this condition. The investigators hope to use the
information from this study to identify new molecular markers to better determine who will or
will not go on to develop esophageal cancer. Patients who have been diagnosed in the past with
Barrett's esophagus will be asked to participate. Patients without Barrett's esophagus will be
asked to take part so that the investigators can compare tissue from patients without the
conditions to those with the conditions.
Inclusion/Exclusion criteria (make this a link to a separate page-see below)
Radiofrequency Ablation and Barrett’s Esophagus
BETRNet funded study (link to UPENN’s BETRNet)
Principal Investigators: Gary Falk, Gregory Ginsberg, John Lynch
The overall goals of the two aims are to identify biomarkers of non-response to therapy and of
recurrent intestinal metaplasia after successful eradication.
This Project is designed to identify biologically-based and clinically-useful biomarkers of tissue
at risk for cancer progression as well as of response to ablation therapy. These results will result
in improved risk stratification in Barrett’s esophagus and allow for better targeting of resources
for patients who are candidates for ablative therapy, while simultaneously providing key
information regarding the origins of Barrett's esophagus.
Inclusion/Exclusion criteria (make this a link to a separate page-see below)
Chemoprevention in Barrett’s Esophagus
Cancer Prevention Network Trial (link to http://cancerpreventionnetwork.org/)
Principal Investigators: Gary Falk
This is a multi-institutional, randomized, double blind, placebo controlled phase II trial
evaluating the use of metformin hydrochloride in preventing esophageal cancer in patients with
Barrett's esophagus.
Inclusion/Exclusion criteria (make this a link to a separate page-see below)
Familial Barrett’s Esophagus Study
Principal Investigators: Gary Falk
BETRNet funded study (link to Case Western BETRNet
http://cancer.case.edu/research/betrnet/projects/index.html)
A collaborative multi-center study evaluating the genetic and environmental determinants of
Barrett’s esophagus and esophageal adenocarcinoma.
The aim is to define the epidemiology and genetics of Barrett’s esophagus and esophageal cancer
in families affected with Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s
esophagus and esophageal cancer occur at a younger age in these families suggesting that
familial Barrett’s esophagus is a genetically inherited disease.
Inclusion/Exclusion criteria (make this a link to a separate page-see below)
Notch Signaling and Novel Biomarkers for Barrett’s Esophagus
BETRNet funded study (link to UPENN’s BETRNet)
Principal Investigators: Gary Falk, Gregory Ginsberg, John Lynch
Prospective cohort study of patients with BE, with or without associated dysplasia or
adenocarcinoma, and controls with and without GERD
This study hopes to identify new molecular markers in the tissue of Barrett's esophagus that will
help physicians better understand and manage this condition. The investigators hope to use the
information from this study to identify new molecular markers to better determine who will or
will not go on to develop esophageal cancer. Patients who have been diagnosed in the past with
Barrett's esophagus will be asked to participate. Patients without Barrett's esophagus will be
asked to take part so that the investigators can compare tissue from patients without the
conditions to those with the conditions.
To discuss whether you are eligible to enroll in these studies
Contact: Maureen DeMarshall 215-349-8546 or [email protected]
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Inclusion Criteria:
For BE patients:
History of histologically confirmed BE, defined as endoscopically-suspected BE with intestinal
metaplasia with globlet cells on esophageal biopsies,
BE length C1M1 or C0M2
Age 18 years
Exclusion Criteria:
History of gastric or esophageal surgery
Inability to give informed consent
Erosive esophagitis seen on upper endoscopy
History of prior endoscopic therapy for BE 5 (for controls) History of intestinal metaplasia on
previous esophageal, GE junction or cardia biopsies.
Radiofrequency Ablation and Barrett’s Esophagus
BETRNet funded study (link to UPENN’s BETRNet)
Principal Investigators: Gary Falk, Gregory Ginsberg, John Lynch
The overall goals of the two aims are to identify biomarkers of non-response to therapy and of
recurrent intestinal metaplasia after successful eradication.
This Project is designed to identify biologically-based and clinically-useful biomarkers of tissue
at risk for cancer progression as well as of response to ablation therapy. These results will result
in improved risk stratification in BE and better targeting of resources for patients who are
candidates for ablative therapy, while simultaneously providing key information regarding the
origins of Barrett's esophagus.
To discuss whether you are eligible to enroll in these studies
Contact: Maureen DeMarshall 215-349-8546 or [email protected]
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Inclusion Criteria:
Barrett's esophagus with high grade dysplasia or intramucosal (early) adenocarcinoma.
BE length ≥ 2 cm and ≤ 8 cm.
Able to return every 3 months for one year after ablation
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Exclusion Criteria:
Patients who are unable to be compliant with follow-up endoscopies
patients who cannot tolerate Proton Pump inhibitors
pre-existing esophageal strictures
pregnant or nursing women
Chemoprevention in Barrett’s Esophagus
Cancer Prevention Network Trial (link to http://cancerpreventionnetwork.org/)
Principal Investigators: Gary Falk
This is a multi-institutional, randomized, double blind, placebo controlled phase II trial
evaluating the use of metformin hydrochloride in preventing esophageal cancer in patients with
Barrett's esophagus.
To discuss whether you are eligible to enroll in these studies
Contact: Maureen DeMarshall 215-349-8546 or [email protected]
Inclusion/Exclusion Criteria
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DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of Barrett esophagus, with no dysplasia, indeterminate for
dysplasia, or low-grade dysplasia as defined by the presence of specialized columnar epithelium
on histology and ≥ 2 cm of involvement on endoscopy
Adequate Barrett mucosa, which is defined as ≥ 1 out of 4 research samples (i.e., ≥ 25%) with ≥
50% intestinal metaplasia in biopsies required to satisfy the endpoints of the study
No history of esophageal carcinoma
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No erosive esophagitis or ulcerative esophagitis, unless treatment with a proton pump inhibitor
(PPI) results in healed erosions or ulcers prior to entry endoscopy
No history of high-grade dysplasia or cancer of the esophagus (confirmed locally by
esophagogastroduodenoscopy [EGD] and Pathology reports)
No ulcer, plaque, nodule, stricture, or other luminal irregularity within the Barrett segment,
unless clinical biopsy produces no evidence of high-grade dysplasia or cancer
PATIENT CHARACTERISTICS:
ECOG performance status ≤ 1
Hemoglobin ≥ 10 g/dL
Leukocytes ≥ 3,000/μL (≥ 2,500/μL for African-American participants)
Absolute neutrophil count ≥ 1,500/μL (≥ 1,000/μL for African-American participants)
Platelets ≥ 100,000/μL
Total bilirubin ≤ institutional upper limit of normal (ULN)
AST (SGOT) and ALT (SGPT) ≤ 1.5 times institutional ULN
Creatinine ≤ institutional ULN
Willingness to provide tissue samples for research purposes
No contraindication to esophagogastroduodenoscopy (EGD)
Willingness, for both men and women, to use adequate contraception (hormonal or barrier
method of birth control; surgical intervention; abstinence) prior to study entry and for the
duration of study participation
A negative (serum or urine) pregnancy test done ≤ 7 days prior to Pre-Registration, for women of
childbearing potential only
No pregnant or nursing women
No participants with diabetes mellitus
No history of vitamin B12 deficiency or megaloblastic anemia
No history of lactic acidosis
No diseases associated with weight loss: anorexia or bulimia
No history of allergic reactions attributed to compounds of similar chemical or biologic
composition to metformin
No participants with HIV, cirrhosis of any cause, NASH (non-alcoholic steatohepatitis), or
hepatitis (auto-immune or infectious)
For participants diagnosed with any other hepatic impairment, consult with protocol principal
investigator (PI)
No metabolic acidosis, acute or chronic, including ketoacidosis
No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection,
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric
illness/social situations that would limit compliance with study requirements; this includes
significant medical conditions including renal failure, hepatic failure, sepsis, and hypoxia
No genetics disorders such as family history of hereditary gastrointestinal polyp disorder (e.g.,
familial adenomatous polyposis [FAP], hereditary non-polyposis colorectal cancer [HNPCC],
Peutz-Jegher disease)
No chronic alcohol use or a history of alcohol abuse (defined as ingestion of ≥ 3 drinks per day)
No kidney disease or renal insufficiency (defined as serum creatinine above institutional upper
limit of normal)
No history of other cancer(s) with the following exceptions:
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Non-melanoma skin cancers
Cancer(s) for which diagnosis and treatment was completed ≥ 3 years prior to pre-registration
PRIOR CONCURRENT THERAPY:
Currently on a proton pump inhibitor (PPI) ≥ 4 weeks (any PPI taken at least once daily is
acceptable)
No medication(s) for weight loss ≤ 2 months prior to Pre-Registration
No treatment with other oral hypoglycemic agents
No participant use of non-study metformin or other biguanides
No receipt of any other investigational agents ≤ 3 months prior to Pre-Registration, except
innocuous agents with no known interaction with the study agent (e.g., standard dose
multivitamins or topical agents for limited skin conditions), at the discretion of the Protocol Lead
Investigator at each Participating Site
No participants who have undergone ablation or other local therapies (e.g., percutaneous
dilatational tracheostomy [PDT], cryotherapy, radiofrequency, argon plasma coagulation [APC],
or multipolar electrocoagulation [MPEC])
Patients treated with endoscopic mucosal resection [EMR] allowed
No participants anticipating elective surgery during the study period
No participants planning to undergo elective radiologic studies involving intravascular
administration of iodinated contrast materials
Familial Barrett’s Esophagus Study
Principal Investigators: Gary Falk
BETRNet funded study (link to Case Western BETRNet
http://cancer.case.edu/research/betrnet/projects/index.html)
A collaborative multi-center study evaluating the genetic and environmental determinants of
Barrett’s esophagus and esophageal adenocarcinoma.
The aim is to define the epidemiology and genetics of Barrett’s esophagus and esophageal cancer
in families affected with Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s
esophagus and esophageal cancer occur at a younger age in these families suggesting that
familial Barrett’s esophagus is a genetically inherited disease.
To discuss whether you are eligible to enroll in these studies
Contact: Maureen DeMarshall 215-349-8546 or [email protected]
Inclusion/Exclusion Criteria:
Eligible cases will be defined as those patients and their family members who meet the following
criteria:
Barrett's esophagus confirmed by review of pathology and endoscopy report or adenocarcinoma
of the esophagus or family members of person with Barrett's esophagus or adenocarcinoma of
the esophagus.
Male or female age 18 or older at time of enrollment or male or female less than 18 years of age
at time of enrollment with parental consent. Ability to give informed consent, if patient is age 18
or older.