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Current Clinical Trials

FOR PATIENTS AND PHYSICIAN REFERRALS

Search by:

Barrett's Esophagus

Achalasia

BRCA1 & BRCA2

Carcinoid Syndrome

C. Difficile


Crohn's Disease

Colon Cancer

Eosinophilic Esophagitis

Familial Hereditary Polyposis (FAP)

Familial Pancreatic Cancer

Irritable Bowel Syndrome (IBS)

Hepatology

Inflammatory Bowel Disease

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BARRETT'S ESOPHAGUS
For all studies contact: Maureen DeMarshall 215-349-8546  Email

Wide Area Transepithelial Sample 3-Dimensional Esophageal Biopsy (WATS) combined with computer assisted analylsis for the Detection of Esophageal Dysplasia:  A Prospective, Randomized, Tandem Study:

The purpose of this study is to see if the addition of a brush biopsy to standard, forceps biopsy improves the detection of precancerous changes in the esophagus (food pipe) in people with Barrett's esophagus.  Barrett's esophagus is a change in the normal lining of the esophagus due to chronic acid reflux.  Funds for conducting this research are provided by CDx Diagnostics, the company that developed the brush biopsy instrument.

Notch Signaling and Novel Biomarkers for Barrett's Esophagus - BETRNet funded study

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.

Criteria

Radiofrequency Ablation and Barrett's Esophagus - BETRNet funded study

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.

Criteria

Familial Barrett's Esophagus - 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.

Criteria

BE Tissue Collection
Cell culture from GERD and Barrett's Esophagus

Receptos Study
Gary W. Falk, MD MS
Contact: Maureen DeMarshall 215-349-8546 Email

Receptos is “A Phase 2, Multi-center, Multi-national, Randomized, Double-blind, Placebo-controlled Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of RPC4046 in Adult Subjects With Eosinophilic Esophagitis.” The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment of Eosinophilic Esophagitis (EoE). ClinicalTrials.gov Identifier:
NCT02098473

Criteria


ACHALASIA


Peroral Endoscopic Myotomy (POEM) for Esophageal Motility

Ginsberg, Gregory, MD
Contact: Maureen DeMarshall 215-349-8546 Email
              Carly Price 215-349-8556 Email

The investigators wish to monitor the adoption of a new, incisionless approach to performing a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic Myotomy (POEM), will provide less-invasive treatment for esophageal achalasia, ideally providing similar if not better outcomes (safety and efficacy) as the Heller myotomy. The investigators hope to enroll 10 patients with a clinical diagnosis of achalasia who meet inclusion criteria.

The POEM procedure has been done in many hospitals without any research associated with it. Dr. Ginsberg, Dr. Chandrasekhara and Dr. Kochman will perform the procedures after being trained. Dr. Ginsberg has personally witnessed the performance of 10 POEM procedures and has performed in a swine model. The PI is credentialed to initiate POEM at HUP with the first case to be proctored by an experienced operator. The PI will then proctor the other adopters. The investigators would like to evaluate the safety of it and the effectiveness of it. The investigators will use their symptom scores and radiology tests pre- and post-POEM to evaluate effectiveness.

EndoFLIP Use in Upper GI Tract Stenosis
Kochman, Michael Lee, MD
Contact: Maureen DeMarshall 215-349-8546 Email
              Carly Price 215-349-8556 Email

The purpose of this study is to investigate the use of a functional luminal imaging probe to characterize benign esophageal luminal strictures before and after dilation and identify predictors of response to therapy. Patients will be evaluated during endoscopy using functional luminal imaging (EndoFLIP; Crospon Medical Devices, Galway, Ireland) to characterize the geometry of benign luminal esophageal narrowing before and after dilation.


BRCA1 & BRCA2

Screening for Pancreatic Cancer in patients with BRCA1/2 Mutations
Rustgi, Anil K., MD
Contact: Maureen DeMarshall 215-349-8546 Email
              Carly Price 215-349-8556 Email

The study is a prospective, observational, case-control study evaluating the utility of endoscopic ultrasound for the identification of preneoplastic and neoplastic pancreatic lesions in patients at high risk for pancreatic cancer, specifically those with BRCA1/2 mutations.



CARCINOID SYNDROME

TELESTAR
Metz, David C., MD
Contact: Julie Starr or Carly Price

A Phase 3, Randomized, Placebo-controlled, Parallel Group, Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome Not Adequately Controlled by Somatostatin Analog (SSA) Therapy

The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.

Criteria

TELECAST
Metz, David C., MD
Contact: Julie Starr or Carly Price

Phase 3, Randomized, Placebo-controlled, Multicenter, Double-blind Study to Evaluate the Safety and Efficacy of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome

The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

Criteria

NETTER-1
Metz, David C., MD
Contact: Julie Starr

A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours (NETTER-1)

The purpose of this study is to:

  • compare Progression Free Survival (PFS) after treatment with 177Lu-DOTA0-Tyr3-Octreotate plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in patients with inoperable, progressive (as determined by Response Evaluation Criteria in Solid Tumors [RECIST] Criteria), somatostatin receptor positive, well-differentiated neuroendocrine tumours of the small bowel (midgut carcinoid tumours).
  • compare the Objective Response Rate (ORR) between the two study arms
  • compare the Overall Survival (OS) between the two study arms
  • compare the Time to Tumour Progression (TTP) between the two study arms
  • evaluate the safety and tolerability of 177Lu-DOTA0-Tyr3-Octreotate
  • evaluate the health related quality of life (QoL) as measured by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-G.I.NET21 questionnaire
  • explore the correlation of toxicity outcomes and administered radiation doses corrected for body weight and body surface area
  • explore the correlation of clinical efficacy outcomes with the levels of the biomarkers Chromogranin-A (CgA) in the serum and 5-Hydroxyindoleacetic acid (5-HIAA) in the urine
  • evaluate dosimetry, pharmacokinetics (PK) and ECG in a subset of 20 patients
  • explore the correlation of clinical efficacy outcomes with OctreoScan® tumour uptake score
  • explore the correlation of clinical outcomes with serum levels of Alkaline Phosphatase (AP)


C. DIFFICILE

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD 2)
Rebiotix
Aberra, Faten, MD, MSCE
Contact: Julie Starr or Carly Price

This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.

Criteria


CROHN'S DISEASE

SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry
Secure Registry Study
Aberra, Faten, MD, MSCE
Contact: Carly Price

The purpose of this study is to monitor safety outcomes of patients who have taken Cimzia® as compared to a non- Cimzia® control population. The SECURE Registry's target enrollment is 4000 patients and its objective is to monitor patients for approximately 10 years.

Criteria


COLON CANCER

The Role of in Vivo Real Time Endocytoscopy in Diagnosing Colorectal Neoplasia
Buchner, Anna, MD
Contact: Julie Starr or Carly Price

Endocytoscopy and Colorectal Neoplasia
This is a pilot study to evaluate the role of endocytoscopy in classifying colorectal polyps in vivo. The primary outcomes are to determine the key endocytoscopy image features of neoplastic and non-neoplastic colorectal polyps. The target population includes adult subjects undergoing screening and surveillance colonoscopies.


EOSINOPHILIC ESOPHAGITIS (EoE)

Receptos
Falk, Gary W., MD, MS
Contact: Maureen DeMarshall

Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis
The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of double-blind treatment and 24 weeks of open-label extension.

Regeneron
Falk, Gary W., MD, MS
Contact: Maureen DeMarshall

A Randomized, Double-Blind, Parallel, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Dupilumab in Adult Patients with Active Eosinophilic Esophagitis
This study is being done to evaluate the effect of dupilumab on relieving EoE symptoms and reduce esophageal inflammation in adults.
See Endoflip


FAMILIAL HEREDITARY POLYPOSIS (FAP)

CPP-FAP 310
Rustgi, Anil K., MD
Contact: Julie Starr or Carly Price

Trial of Eflornithine Plus Sulindac in Patients with Familial Adenomatous Polyposis (FAP)

The purpose of this randomized, double-blind, Phase III trial is to determine if the combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single agents in delaying time to the first occurrence of any FAP-related event. This includes: 1) FAP related disease progression indicating the need for excisional intervention involving the colon, rectum, pouch, duodenum and/or 2) clinically important events which includes progression to more advanced duodenal polyposis, cancer or death.

Criteria

Septin9
Rustgi, Anil K., MD
Contact: Julie Starr

Preliminary Evaluation of Septin9 in Patients with Hereditary Colon Cancer Syndromes

This is an observational, case-control study evaluating the quantitative level of Septin9 in plasma pre- and post-colectomy in hereditary colorectal cancer (CRC) syndrome patients (Familial Adenomatous Polyposis (FAP), Lynch syndrome (also known as HNPCC), and Multiple Adenomatous Polyposis (MAP, also known as MYK/MYH) cases) and genetically related FAP-family members as controls and references.


FAMILIAL PANCREATIC CANCER

CAPS-5
Rustgi, Anil K., MD
Contact: Maureen DeMarshall or Carly Price

The Cancer of the Pancreas Screening-5 (CAPS5) Study

Aim #1: To evaluate pancreatic fluid mutations and circulating pancreatic epithelial cells as accurate markers of neoplasia by comparing their prevalence in cases with sporadic pancreatic neoplasia to healthy and disease controls.

Aim #2: To compare the prevalence of pancreatic fluid mutations and circulating pancreatic epithelial cells among a prospective cohort of individuals with sporadic pancreatic cysts undergoing pancreatic surveillance.

Aim #3: To determine the prevalence of pancreatic lesions, pancreatic fluid mutations and circulating pancreatic epithelial cells among a large cohort of high-risk individuals undergoing pancreatic screening and surveillance of a new cohort in which screening is begun at age >55.

Criteria

See  Screening for Pancreatic Cancer in patients with BRCA1/2 Mutations


IRRITABLE BOWEL SYNDOME (IBS)

Irritable Bowel Syndrome in the Obese Population (IBSOP)Pickett-Blakely, Octavia, MD
Contact: Carly Price

The purpose of this research is to improve our understanding of the relationship between excess body weight and bowel symptoms. In this study we will investigate if those with excess body weight have a greater chance of having bowel symptoms that affect their life. We will also investigate what happens to those bowel symptoms when an individual loses weight. We will compare how bowel symptoms change in individuals who lose weight following weight loss surgery and a non-surgical weight loss program (e.g. medical weight loss).


HEPATOLOGY

BMS AI444-257
Contact: Grace Kim Lee

A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination with Sofosbuvir for the Treatment of Subjects with Chronic Hepatitis C and Decompensated Cirrhosis or Post-Liver Transplant Subjects with Chronic Hepatitis C Recurrence

Conatus IDN-6556-07
Contact: Grace Kim Lee

A Multicenter, Double-Blind, Sponsor-Open Trial of IDN-6556 in Subjects Who had Hepatitis C Virus (HCV) Reinfection and Liver Fibrosis following Orthotopic Liver Transplantation for Chronic HCV Infection and Who Subsequently Achieved a Sustained Virologic Response Following anti-HCV Therapy

EDRN
Contact: Grace Kim Lee

Hepatocellular Carcinoma Early Detection Strategy study

Galectin GT-026
Contact: Grace Kim Lee

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients with NASH Cirrhosis

Intercept 727-207
Contact: Grace Kim Lee

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects with Primary Sclerosing Cholangitis

Intercept 727-302
Contact: Grace Kim Lee

A Phase 3b, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis

Ocera OCR002-H209
Contact: Grace Kim Lee

A Multicenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (ornithine phenylacetate) in Hospitalized Patients with Cirrhosis and Associated Hyperammonemia with an Episode of Hepatic Encephalopathy

Abbvie M14-227
Contact: Grace Kim Lee

An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin in Adults with Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus

Infection and Decompensated Cirrhosis (TURQUOISE-CPB)
Contact: Grace Kim Lee

A Multi-Center Group to Study Acute Liver Failure (ALF)  -- ENROLLING

STOP-ALF
Contact: Grace Kim Lee

A Phase 2a Study to Evaluate the Safety and Tolerability of OCR-002 (ornithine phenylacetate) in the treatment of patients with Acute Liver Faliure/Severe Acute Liver Injury (STOP-ALF) – ENROLLING

M14-226
Contact: Grace Kim Lee

An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevie/Ritonavir and Dasabuvir with or without Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, with Severe Renal Impairment or End-Stage Renal Disease (RUBY-1) - ENROLLING

M14-726
Contact: Grace Kim Lee

An Open-Label Study to Evaluate the Safety and Efficacy of the Combination of Ombitasvir/ Paritaprevir/r ± Dasabuvir with Ribavirin (RBV) in Adult Patients with GT1 or GT4 Chronic HCV Infection and Response to Prior Treatment of Early Stage Hepatocellular Carcinoma – ENROLLING

GS-384-1497
Contact: Grace Kim Lee

A Phase 2, Randomized, Open Label Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 alone or in Combination with Simtuzumab (SIM) in Subjects with Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3 – ENROLLING

 

INFLAMMATORY BOWEL DISEASE
For all studies contact: Susan Parrott 215-662-8919 Email

CZP4UC

Certolizumab Pegol for the Treatment of Moderate to Severe Ulcerative Colitis: An Open Label Study

MERIT-UC

Randomized, double blind, prospective trial investigating the efficacy of methotrexate in induction and maintenance of steroid free remission in ulcerative colitis (Methotrexate Response In Treatment of UC)

PIANO

Inflammatory Bowel Disease and Neonatal Outcomes

I3:  IBD IMMUNOLOGY INITIATIVE
Contact:  Research Coordinator, 215-898-0161, I3Study@uphs.upenn.edu

A translational clinical and tissue database study.

Actively enrolling all Crohn's disease and Ulcerative Colitis patients seen within the University of Pennsylvania Health System.  The aim is to understand abnormalities in the immune system and other factors that impact IBD.

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