"Improving Lives One Study at A Time"

The Digestive Disease Clinical Research Unit (DDCRU) facilitates clinical research activity for the following clinical disciplines: Colorectal Surgery, Gastroenterology and Hepatology, Liver Transplant, Hepatobiliary, Enterostomal Therapy and Nutrition. The DDCRU is an integrated multidisciplinary team of over 40 clinical research personnel.

With experience in surgical and medical clinical trials as well as database and epidemiological studies, the DDCRU offers diverse expertise within the field of clinical research.

The clinical trials branch of the Digestive Disease Clinical Research Unit are project team based, allowing studies to be conducted by a subset of research personnel with specific expertise.

Currently in the DDCRU, our clinical trials project teams are:

• Device and Surgery
• Endoscopy and Capsule
• Hepatology
• Inflammatory Bowel Disease and Nutrition
• Liver Transplant and Hepatobiliary

In addition to experience with various types of clinical research, the DDCRU facilitates budget and contract negotiation and institutional and federal regulatory compliance.

For more information about enrolling studies in the Digestive Disease Institute, please call 216.636.5340 or email DDI-Research@ccf.org.

Get Involved!

To enroll in a clinical study, call 216.636.5340 or email DDI-Research@ccf.org.

Digestive Disease Clinical Research Unit is actively enrolling clinical trials in the following areas:

»Device and Surgery

Get Involved!

To enroll in a clinical study, call 216.636.5340 or email DDI-Research@ccf.org.

A pilot study to evaluate the potential of using a collagen implant to reinforce an overlapping sphincter repair

• Massarat Zutshi, MD

This trial has been developed to patients suffering from fecal incontinence. The purpose of this study is to investigate the effectiveness and safety of Permocol®, a collagen implant, in an overlapping sphincter repair to reinforce the soft tissue. After the surgical procedure to place the implant, follow-up visits will be required for 6 months, and endoanal ultrasounds will be used to evaluate the area of repair.

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A Randomized Controlled Trial to Evaluate Hemorrhoidal Banding, Hemorrhoidal Arterial Ligation and Stapled Hemorrhoidectomy in the Treatment of Grade 2, 3 and 4 Hemorrhoids

• Massarat Zutshi, MD

Patients enrolled in this study have been diagnosed as having grade 2, 3 or 4 hemorrhoidal disease. Three different hemorrhoid treatment procedures will be studied: hemorrhoid banding, stapled hemorrhoidectomy and hemorrhoid arterial ligation. The study will compare the time taken for the procedure; how much pain an individual experiences after the procedure; when an individual returns to work and/or normal activity after the procedure; any complications that occur after the procedure and any recurrence of hemorrhoidal disease.

All patients will be asked to record their pain scores one hour after the procedure, while still in the clinic or recovery room setting, and then every 8 hours at home for the next 24 hours. A research nurse will call every 24 hours for the next 3 days at home to ask questions about pain. Patients will be requested to complete questionnaires at 4-6 weeks and at 12-14 weeks after the procedure.

Patients will also be contacted by phone at approximately 6 months and 12 months after the procedure to ask you several questions about recovery, complications, and any recurrence of hemorrhoidal disease. Each phone call should take approximately 5 minutes to complete.

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Surgisis 24 month participation study

• Massarat Zutshi, MD

Surgisis is an implant that is used as reinforcement when undergoing a sphincter repair, for patients with Fecal Incontinence. This disorder affects woman more often than men, but is equally debilitating to patients. The Sugisis study requires a total of 24 month participation with follow-up visits at 6, 12 and 24 months after surgery-with a series of questionnaires. Patients are identified by inclusion/exclusion criteria. Patients who have Fecal Incontinence due to anterior defect in the external sphincter or both internal and external sphincters are eligible. Patients are then randomized to product or control group. This product is to reinforce the overlapping sphincter repair procedure, to improve patient’s quality of life.

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Z6051 A Phase 3 randomized trials comparing Open vs Laproscopic resection for rectal cancer

• Luca Stocchi, MD

This study is for patients who are diagnosed with stage 1-3 rectal cancer. This study is evaluating the efficacy of Open rectal resection vs Laproscopic rectal resection for patients diagnosed with rectal cancer. The study requires a long term 5yr follow-up after surgery. Patients are identified by cancer staging, location of the cancer and other eligible criteria. There are a series of follow-up visits with questionnaires, colonoscopy at 12 months and periodic lab work for the study. Patients who consent to participation are randomized to 2 arms-Open vs Laproscopic. Follow-up visits are with their designated physician. This study is a Multi-center trial looking to enroll 480 patients.

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Case 1208 Timing of rectal cancer response to Chemoradiation

• David Dietz, MD

This study is for patients diagnosed with stage 2-3 rectal cancer. This study is focusing on optimal timing between Chemoradiation therapy and surgery for patients with rectal cancer. Studies have shown with this combination of therapy and surgery, often by the time surgery occurs, patients have had their tumors’ shrink or disappear and the outcome for recurrence is better with this response. The study is a multi-center trial that is looking at 4 groups of subjects with each group having Chemoradiation and surgery at different intervals. Patients will have their standard of care chemotherapy and radiation treatments with certain timing intervals and 1 physician follow-up appointment to screen response to therapy. Patients end participation in study after surgery.

»Endoscopy, Esophageal and Capsule

Get Involved!

To enroll in a clinical study, call 216.636.5340 or email DDI-Research@ccf.org.

Evaluation of Angiogenesis for Diagnosis of Indeterminate Biliary Strictures

Mansour Parsi, MD

This pilot study is designed to enroll 10 patients (5 with malignant and 5 with benign strictures) who are undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.

Blood, ductal brushings and biopsies will be obtained for measurement of Vascular Endothelial Growth Factor (VEGF), which may help distinguish malignant from benign biliary strictures. In many patients, the first sign of a pancreatobiliary cancer is a stricture of the bile duct.

Early and accurate diagnosis of pancreatobiliary malignancy offers the best chance of a surgical cure while avoiding unnecessary major surgery in patients with benign disease.

»Hepatology

Randomized Controlled Trial of Omega 3 Fatty Acids in the Treatment of Non Alcoholic Steatohepatitis in Patients with Type 2 Diabetes Mellitus (PUFA)

Get Involved!

To enroll in a clinical study, call 216.636.5340 or email DDI-Research@ccf.org.

• Srinivasan Dasarathy, MD

This double blind, placebo controlled study is open to people who have Type 2 diabetes and non-alcoholic steatohepatitis. After the screening evaluation (which may include a liver biopsy), patients in be randomized into either a placebo or Omega 3 Fatty Acids group.

Members of the placebo group will take a supplement containing corn oil, while members of the Omega 3 fatty Acid group will take a supplement containing fish oil. Treatment will last for 48 weeks, and will include blood work, questionnaires, and a DEXA scan. Follow-up visits will be schedule up to 24 weeks after the completion of the study. A liver biopsy will be performed at the end of the trial.

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of HPN-100 for Maintaining Remission in Subjects with Cirrhosis and Episodic Hepatic Encephalopathy (HALT-HE) [Sponsored by Hyperion Therapeutics, Inc.)

• Robert O’Shea, MD

This is a phase 2 study of HPN-100 in subjects with hepatic encephalopathy (HE) consisting of an open label safety lead-in (Part A), followed by randomized, double-blind, placebo-controlled treatment (Part B).   Part A consists of an open-label, dose-escalation lead-in to assess HPN-100 safety and  drug pharmacokinetics . Approximately 10 subjects with HE and cirrhosis classified as Child Pugh B or C will be enrolled, for a period of up to 28 days. Subjects who enrolled in and completed Part A may continue to Part B as long as they meet the eligibility criteria.

Patients who continue to Part B will be randomly assigned to a double-blind assessment of HPN-100.  The patient will either continue to receive the HPN-100 or a matching placebo for 16 weeks. Subjects will be assessed daily for their HE symptoms by their caregiver and frequently by the investigator at office visits.

Subjects who experience a documented HE event during the study will be allowed to receive emergency management, including rescue medications and/or hospitalization for management of their HE event.

»Inflammatory Bowel Disease and Nutrition

Get Involved!

To enroll in a clinical study, call 216.636.5340 or email DDI-Research@ccf.org.

Role of Hepcidin in the Pathogenesis of Chronic Anemia in Patients with Ileal Pouch-Anal Anastomosis

• Bo Shen, MD

This study seeks to determine the cause of anemia in patients with ileal pouch-anal anastomosis by measuring inflammatory proteins (called cytokines) and hepcidin in the urine, blood, and biopsy specimens of the pouch.

We believe that anemia in this patient population may be related to a high level of hepcidin; a protein produced by the liver in response to any inflammatory condition of the body. By identifying the cause of the anemia we might be able to treat it more effectively in the future.

This study seeks to enroll 40 people. (20 people with anemia and 20 patients without anemia) from the Cleveland Clinic Foundation outpatient clinic, Inflammatory Bowel Disease Center.

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Study Title: Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease (Sponsored by Millennium Pharmaceuticals, Inc.)

• Bret Lashner, MD

The Millennium study is a multi-national, randomized, blinded, placebo-controlled trial to assess the efficacy and safety of Vedolizumab (MLN0002), given by infusion (through a vein in your arm) in patients with moderately to severely active Crohn’s disease.

The target population is adults with moderately to severely active Crohn’s Disease for at least three months who have demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance to Immunomodulator and/or TNF antagonist therapy.

This study comprises of two phases: Induction Phase and Maintenance Phase.

During the Induction phase, patients will receive treatment (MLN0002 or Placebo) two times, Week 0 and Week 2. The Induction phase ends at Week 6. All patients will then enter the Maintenance phase which lasts 46 weeks. Infusions of the study drug or placebo will occur every 4 weeks during the Maintenance phase. After the Week 52 assessments, patients may be eligible to enroll in a long term Safety study to receive active treatment with MLN0002

»Liver Transplant and Hepatobiliary

Get Involved!

To enroll in a clinical study, call 216.636.5340 or email DDI-Research@ccf.org.

Hepatocellular Carcinoma (HCC) Genetic Profiling: Searching for Predictors of Tumor Recurrence After Liver Transplantation

• Federico Aucejo, MD

In an era of organ shortage, the utilization of a risk scoring system could significantly improve liver transplant patient selection criteria. This study is seeking to identify biological and genetic (DNA and RNA) markers from blood and/or liver tissue that will predict post-therapy tumor recurrence in patients with hepatocellular carcinoma (HCC). These markers may allow physicians to better predict patient outcomes after liver transplant due to HCC/cirrhosis, versus other treatment therapies.

Patients who may be eligible for this study have been diagnosed with cirrhosis, approved for liver transplant, and have HCC nodules at least 2 cm in size. Blood samples and a liver biopsy will be the initial procedures required.

After liver transplantation, each patient will be followed for 5 years according to transplant standard of care guidelines. During the first year after the transplant, patients will be assessed every three months.

The care will include CT or MRI imaging of the chest, pelvis and abdomen, as well as tumor and genetic marker testing from blood samples. In the second, third, fourth and fifth years of follow-up, the testing from the first year will be repeated every six months rather than every three months.

For more information about enrolling studies in the Digestive Disease Institute, please call 216.636.5340 or email

• DDI-Research@ccf.org.

»Pelvic Floor Dysfunction Database

• Tracy Hull, MD

2007

The purpose of this database is to collect medical, surgical, demographic and quality of life information on patients that are seen at the Cleveland Clinic, Department of Colorectal Surgery for a diagnosis of pelvic floor dysfunction. This would include multiple diagnoses that had to do with Pelvic Floor Dysfunction. This would include, Fecal Incontinence, Rectal Prolapse, and Constipation.

»Colon and Rectal Cancer Database

• Ian Lavery, MD

1998

The purpose of this database is to collect pre-op symptoms, diagnosis, surgery, pathology reports, QOL, treatment and recurrence of patients diagnosed with Colon and/or Rectal Cancer. Patients are also asked to consent to tissue and blood banking.

»Laparoscopic Database

• Dan Geisler, MD

1991

The Laparoscopic Colorectal Surgery Database is a database designed to capture the quality of life data of patients undergoing laparoscopic surgery. The Laparoscopic database collects data on demographics, surgical treatments, and preoperative and postoperative quality of life questionnaires.

»Pelvic Pouch Database

• Feza Remzi, MD

The purpose of this database is the collection and storage of medical, surgical, demographic and quality of life information gathered from patients at the Cleveland Clinic who are undergoing Pelvic Pouch surgery to assess short and long term quality of life, health and functional status of these patients. Data is collected through a series of preoperative and postoperative questionnaires as well as chart review.

»Diverticular Database

• Ravi Kiran, MD

2004

The purpose of the registry is to better understand diverticular disease, how patients with diverticulitis manage the disease through surgery, and how diverticular disease impacts a patient's quality of life. We collect medical, surgical, demographic and quality of life information for a year.

»Ripka Family Database for Crohn’s Disease Research

• Scott Strong, MD

The purpose of this database is to collect medical, surgical, demographic and quality of life data on patients with Crohn's disease and to research into the cure and reasons for relapses of the disease. All patients with a diagnosis of Crohn's will be asked to participate in this long-term research.

»Familial Adenomatous Polyposis Database

• James Church, MD

The David G. Jagelman Inherited Colon Cancer registries goal is to prevent death by providing the best care to patients and families, to promote knowledge of the risk and implications of a family history of colorectal cancer, and to produce important research in areas of concern. Data is collected from electronic, paper or outside medical records and entered into an password secured database.

»Colonoscopy Database

• James Church, MD

The Colonoscopy database is a collection of medical, demographic and procedural data extracted during the colonoscopy procedure.

»Familial Pancreatic Cancer Surveillance Registry

• Tyler Stevens, MD

The main purpose of this registry will be to gain a better understanding of the outcomes of patients who undergo familial pancreatic cancer (FPC) surveillance. We collect clinical, endoscopic, and histological data (obtained for purposes of clinical care) on patients evaluated for FPC surveillance in a prospective registry.

»HALO Patient Registry: Ablation of Barrett’s Esophagus

• Gary Falk, MD

The research study is open to persons which have been diagnosed with Barrett’s esophagus, a pre-cancerous change to the lining of the esophagus due to acid reflux. Participants will be asked to undergo an endoscopy to evaluate the lining of the esophagus. (This is done by passing a flexible tube with a camera down a patient’s throat, while she or he is under sedation.) Areas that show evidence of Barrett’s esophagus and dysplasia will be treated with the HALO device during the endoscopy procedure. Patients will be asked to return to the Cleveland Clinic every 2 months for follow-up endoscopies, to allow the physician to monitor healing in the esophagus. Once a biopsy sample confirms that the Barrett’s esophagus has been eliminated, patients will have yearly visits that will include endoscopy (with biopsy) for surveillance. This study is open to persons who are 18 years of age and older, and who are able to give informed consent. This study is also open to patients who have been previously treated with the HALO device for Barrett’s esophagus.

»Cleveland Clinic Barrett’s Esophagitis Registry

• Gary Falk, MD

The registry has two primary roles. The registry has a clinical service role as it is utilized to generate patient reminder letters for surveillance procedures. It also serves as a potential source of patients for all Barrett's esophagus research at the Cleveland Clinic. All patients are entered into the registry based on the information derived from a data sheet which is completed at the time of the endoscopic procedure.

»The Cleveland Clinic Foundation Inflammatory Bowel Disease DNA Bank

• JP Achkar, MD

The purpose of this database is to study the genetics that cause Crohn’s disease and ulcerative colitis. Patients and a significant other are asked to donate 2 tubes of blood and answer a brief questionnaire.

»Adenoma Registry

• Carol Burke, MD

1987

The purpose of the registry is to collect patient information and procedural and pathologic results of lower endoscopic procedures done on Cleveland Clinic Foundation patients. This data can be used to address risk factors for colorectal neoplasia, proper surveillance intervals and is used to send a recall letter to patients to advise them when they are due for their next colonoscopy according to national guidelines.

»Laparoendoscopic Treatment of Gastric Stromal Tumors

• R. Matthew Walsh, MD

The purpose of this database is to collect data on patients presenting with gastric stromal tumors that have surgical intervention with a laparoendoscopic procedure.
The data is collected from the electronic chart and hard copy medical records. Information regarding symptoms, diagnostic work up, post operative surgical course and follow up contact regarding symptoms and surveillance is collected.

»Pancreatic Cystic Neoplasm

• R. Matthew Walsh, MD

This purpose of this database is to identify trends in patients presenting with pancreatic cysts and looking at standard of care testing for diagnosis and treatment.. A mail out letter and phone script are used to follow up with patients inquiring on symptoms and continued surveillance of pancreatic cysts by CT scan.

»Comprehensive Liver Cancer Database

• Federico Aucejo, MD

The purpose of this database is to collect medical, surgical, non-surgical treatments and surgical and non-surgical outcomes of patients with primary liver cancer.

»Liver Donor/Recipient Outcomes Database

• Cristino Quintini, MD

To have an organized method to access the outcomes and characteristics of liver transplant patients. This database will allow the filtering of data to answer a particular question, review the data for quality management, and observe trends including survival curves based on, for example, recipient diagnosis, MELD score at the time of transplant, etc.

For more information about enrolling studies, databases and registries in the Digestive Disease Institute, please call 216.636.5340 or email DDI-Research@ccf.org.

»Why Participate?

Patients taking part in DDI clinical research studies at Cleveland Clinic are seen by a team of expert doctors, nurses, technicians, and support staff. Clinical research patients often are first to receive promising new treatments before they become available in the community.

Patients are helping others with the same disease, both today and in the future.

»What are the Risks and Benefits?

It is important to understand that some risks are involved in clinical research, just as in routine medical care and activities of daily living. In thinking about the risks of research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring. Most clinical studies pose risks of minor discomfort, lasting only a short time.

Some volunteer subjects, however, experience complications that require medical attention. The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in research. In addition, the major risks of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study.

Before deciding to participate, you should carefully weigh these risks against possible benefits. You may or may not receive direct benefit for yourself and your condition as a result of participating in research, but in either case, you will know that the knowledge developed may help others.

»What is the “informed consent process”?

Informed consent is the process of providing potential participants with the key facts about a clinical trial before they decide whether to participate. The process of informed consent (providing additional information) continues throughout the study. To help someone decide whether or not to participate, members of the research team explain the details of the study.

Translation or interpretive assistance can be provided for participants with limited English proficiency. The research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and who to contact for further information.

The informed consent document also explains risks and potential benefits. The participant then decides whether to sign the document. Informed consent is not a contract.

Volunteers are free to withdraw from the study completely or to refuse particular treatments or tests at any time. Sometimes, however, this will make them ineligible to continue the study.

»Who supports clinical research studies?

Clinical trials are sponsored or funded by various organizations or individuals, including physicians, foundations, medical institutions, voluntary groups, and pharmaceutical companies, as well as federal agencies such as the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs. Trials can occur at sites as varied as hospitals, universities, doctors’ offices, or community clinics.

»How are studies designed?

Clinical research is conducted according to a plan known as a protocol. The protocol is carefully designed to safeguard the participants’ health and answer specific research questions. A protocol describes the following:

• Who is eligible to participate in the trial
• Details about tests, procedures, medications, and dosages
• The length of the study and what information will be gathered

A clinical study is led by a principal investigator, who is often a doctor. Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness.

Each clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are minimal and are worth any potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected. Federal regulation requires all institutions in the United States that conduct or support biomedical research involving people to have an IRB initially approve and periodically review the research.

»What Are the Main Types of Clinical Trials?

Clinical trials are conducted in "phases." The trials at each phase have a different purpose and help researchers answer different questions.

Phase I trials—Researchers test an experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.

Phase II trials—The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.

Phase III trials—The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.

Phase IV trials—After a drug is licensed (approved by the FDA) or treatment is launched, researchers track its safety, seeking more information about a drug or treatment’s risks, benefits, and optimal use. These long–term studies involving large groups of participants continue to see if any unexpected side effects occur in a small percentage of individuals.

»What happens when a clinical research study is over?

After a clinical trial is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about further testing. After a phase I or II trial, the researchers decide whether to move on to the next phase or to stop testing the agent or intervention because it was unsafe or ineffective. When a phase III trial is completed, the researchers examine the data and decide whether the results have medical importance.

Results from clinical trials are often published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it is published to ensure that the analysis and conclusions are sound. If the results are particularly important, they may be featured in news media and discussed at scientific meetings and by patient advocacy groups before they are published. Once a new approach has been proven safe and effective in a clinical trial, it may become the standard of medical practice.

»What should I consider when deciding to participate?

It is important that patients be well informed and feel confident and secure about participating. Before deciding to participate, you should talk with your own doctors, family members, and Digestive Disease Clinical Research personnel.

Be sure you know the answers to the following questions before you make your decision:

• What is the purpose of the study?
• What is required of me?
• What is my role in the study—am I a healthy volunteer or a patient volunteer?
• Will the study directly benefit me?
• Will the study benefit others?
• Are there risks? If so, what are they and what are the chances that they will occur?
• What discomforts are involved?
• What is the total time involved?
• Are there other inconveniences?
• Have I discussed participation in the study with those who are important to me, such as family and friends?
• Do I wish to participate in this study?

• For more information about enrolling studies in the Digestive Disease Institute, please call 216.636.5340 or email DDI-Research@ccf.org.

Websites

• Clinical Research at the National Institutes for Health
• U.S. Food and Drug Administration

Publications

Family Matters – Winter 2008

• Newsletters – including Healthy Pouch and Crohn's Digest

For more information about Digestive Disease Institute’s clinical research studies, please contact us:

216.636.5340

• DDI-Research@ccf.org