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Clinical Research and Trials in Gastroenterology

Current GI Clinical Studies

ORAL BUDESONIDE SUSPENSION (OBS) IN ADOLESCENT
AND YOUNG ADULT SUBJECTS (18-25 YEARS OF AGE)
WITH EOSINOPHILIC ESOPHAGITIS:
A PHASE II, RANDOMIZED, DOUBLE-BLIND,
PLACEBO-CONTROLLED STUDY WITH AN OPEN-LABEL EXTENSION

To discuss whether you are eligible to enroll in these studies

Contact: Maureen DeMarshall 215-349-8546 or demarshm@mail.med.upenn.edu


Meritage is developing oral budesonide suspension (OBS) for the treatment of patients with EoE. OBS is designed to deliver budesonide to the surface of the esophagus more effectively after swallowing due to the increased viscosity and mucoadhesion of
this suspension, compared to a non-viscous suspension. This is a phase II, randomized, placebo-controlled, double-blind, parallel arm study in subjects aged 18-25 years of age.

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Barrett's Esophagus Clinical Trials

Notch Signaling and Novel Biomarkers for Barrett’s Esophagus

BETRNet funded study

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

To discuss whether you are eligible to enroll in these studies

Contact: Maureen DeMarshall 215-349-8546 or demarshm@mail.med.upenn.edu

Radiofrequency Ablation and Barrett’s Esophagus

BETRNet funded study

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

To discuss whether you are eligible to enroll in these studies

Contact: Maureen DeMarshall 215-349-8546 or demarshm@mail.med.upenn.edu

Chemoprevention in Barrett’s Esophagus

Cancer Prevention Network Trial

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

To discuss whether you are eligible to enroll in these studies

Contact: Maureen DeMarshall 215-349-8546 or demarshm@mail.med.upenn.edu

Familial Barrett’s Esophagus Study

Principal Investigators: Gary Falk

BETRNet funded study

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

To discuss whether you are eligible to enroll in these studies

Contact: Maureen DeMarshall 215-349-8546 or demarshm@mail.med.upenn.edu

Notch Signaling and Novel Biomarkers for Barrett’s Esophagus

BETRNet funded study

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

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.

To discuss whether you are eligible to enroll in these studies

Contact: Maureen DeMarshall 215-349-8546 or demarshm@mail.med.upenn.edu

Radiofrequency Ablation and Barrett’s Esophagus

BETRNet funded study

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.

Inclusion/Exclusion Criteria

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

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

To discuss whether you are eligible to enroll in these studies

Contact: Maureen DeMarshall 215-349-8546 or demarshm@mail.med.upenn.edu

Chemoprevention in Barrett’s Esophagus

Cancer Prevention Network Trial

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

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
  • 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:
    • 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

To discuss whether you are eligible to enroll in these studies

Contact: Maureen DeMarshall 215-349-8546 or demarshm@mail.med.upenn.edu

Familial Barrett’s Esophagus Study

Principal Investigators: Gary Falk

BETRNet funded study

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:

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.

To discuss whether you are eligible to enroll in these studies

Contact: Maureen DeMarshall 215-349-8546 or demarshm@mail.med.upenn.edu

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           INCLUSION / EXCLUSION CRITERIA           

Inclusion Criteria:

For BE patients:

Exclusion Criteria:

 

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University of Pennsylvania | Perelman School of Medicine