Familial GI Cancers Unit

Hepatobiliary Bowel Study

Hepatobiliary Bowel Study (HPB)

For information about the HPB Study, please contact Dr. Alice Wei at 416-340-3111 x2890.

Crohn's and Colitis Canada Inflammatory Bowel Disease GEM Project


For more information: www.gemproject.ca
National Project Office
Toll Free: 1-866-803-9632
Email: info@gemproject.ca

Primary Investigators:
Dr. Kenneth Croitoru (National Project Director)
Dr. Hillary Steinhart (Site Investigator)
Dr. Mark Silverberg (Sub-Site Investigator)

Funding provided by:

Crohn's and Colitis Canada  

The Leona M. and Harry B. Helmsley Charitable Trust




Objective: To identify why some individuals develop Crohn's disease while others do not. This is accomplished by following healthy individuals who are considered to be at higher risk for developing Crohn's disease over several years and assessing several factors before and after a diagnosis of Crohn's disease is made.

Expectation: This research will allow for an improved and more c
omprehensive understanding of how human genetics, environmental factors and microbial changes interact and contribute to the development of Crohn's disease.

Eligibility: Anyone who has been diagnosed with Crohn’s disease with at least one sibling or offspring that is generally healthy and is between 6 and 35 years of age.

Individuals who have been diagnosed with Crohn’s disease: The Proband

o Enrolment involves a brief visit where details regarding their diagnosis are confirmed
o You must have at least one healthy sibling or offspring between the ages of 6 and 35 at the time
of enrolment
o You will be asked to contact or provide contact information for your healthy sibling(s) and/or
offspring so that they can be approached for enrolment into the study

Individuals who have a sibling and/or offspring diagnosed with Crohn’s disease: The Subject

o You must be between the ages of 6 and 35 at the time of enrolment.
o You must have a sibling or parent diagnosed with Crohn’s disease.
o No previous diagnosis of diabetes, IBD or Celiac Disease
o Enrolment involves approximately two 1 hour visits:

  • During the visits, subjects must sign consent to participate in the study, complete environmental, dietary and other questionnaires regarding your medical history
  • Four tubes of blood are collected
  • A stool sample is collected
  • Two urine samples are collected
    o Subjects are contacted every 6 months for at least 6 years to review their health status.
    o If subjects develop Crohn’s disease, the sibling or offspring is asked to answer another
    set of questionnaires and will be asked to provide a repeat of blood, stool and urine samples.

Notes: Healthy siblings and/or offspring who do not develop Crohn’s disease during the study, may be asked to answer the questionnaires and provide another set of blood, stool and urine samples if they are chosen to be a healthy control. This control group is used as a comparison group to help determine why some people develop Crohn’s disease while others do not.

Enrolment: Ongoing.

Barriers and Facilitators to medication compliance in IBD patients

Details of Research
Contact: Jhananiee Subendran, Research Student
416-586-4800 ext 2159

Primary Investigator: Erin Kennedy, MD
Enrolment: Complete

Objective: The main aim of this study is to explore the perspectives of individuals with IBD in Toronto, Canada on barriers and facilitators to the compliance of medication.

Expectation: This research may lead to a better understanding of lower compliance rates, and suggest possible ways to improve rates.
Eligibility: Anyone over 18 years diagnosed with IBD (Crohn’s Disease, Ulcerative Colitis or Indeterminate Colitis), have been on any type of treatment for at least 2 years, and are currently on an immunomodulator (Methotrexate) or biologic (Remicade/Humira/etc).

: Participation involves a one-time interview ~30 minutes with the coordinator. Refreshments will be provided.

We would like to thank you in advance for your interest and continued support.

Please contact Jhananiee Subendran (email jsubendran@mtsinai.on.ca) if you are interested in participating in this study.

Phase III trial of the Safety and Efficacy of CPP-1X/Sulindac Compared with CPP-1X, Sulindac as Single Agents in Patients with Familial Adenomatous Polyposis (FAP)

This is a multicenter study conducted at FAP registries in North America and Europe.  

Objective: To determine if CPP-1X plus Sulindac increases the time to an “FAP disease related event” as compared to CPP-1X alone or Sulindac alone.

These events include 1) disease progression leading to major surgery involving the colon, rectum, pouch, duodenum and/or 2) clinically important events which includes progression to more advanced duodenal polyposis, cancer or death and/or 3) development of large or pre-cancerous polyps in the rectum/pouch.

Another purpose of the study is to determine the amount of the drugs in  the  blood (pharmacokinetics).  This study will also look to see if there  has been improvement in the disease and if there have been changes to one’s quality of life.   Finally, the study will look at the presence of compounds called polyamines in the diet, from a small piece of bowel  tissue and urine to see if they are a marker for response to treatment.

CPP-1X ( eflornithine HCI) and Sulindac are tablets that in previous clinical trials have shown promise in reducing the risk of developing adenomas in non FAP patients who have polyps removed during colonoscopy.

More information can be obtained by visiting: link

IBD Research at the Zane Cohen Centre

Information on research and clinical trials in Inflammatory Bowel Disease

Current Studies

Crohn's Disease & Ulcerative Colitis

Ulcerative colitis

Crohn's Disease

  • Mechanisms of Intestinal Inflammation Following Ileal Resection for Crohn's Disease
    Objective is to evaluate microbial and gene expression factors which are associated with the recurrence of small bowel inflammation following surgery for Crohn’s Disease. This will have practical implications for evaluating which patients are more likely to rapidly recur as well as provide insight into the pathogenesis of Crohn’s Disease.

  • Hepatobiliary Bowel Study

  • RHB-104 in CD

  • Etrolizumab in CD (GA29144)

  • Mongersen in CD (Celgene study)

  • The impact of 6MP metabolite levels on infliximab pharmacokinetics and anti-infliximab antibodies in Crohn's disease (Dr. Seidman study)

  • A Cohort Study to Evaluate the Effectiveness of Drug Concentrations in Predicting Recapture of Response with Weekly ADAlimumab in Crohn’s Disease Subjects with Secondary Loss of Response (PRADA) P15-770

  • Denosumab (A Monoclonal Antibody to Receptor Activator of Nuclear factor-Kappa B ligand (RANKL) in Crohn's disease (Dr. Bernstein study))

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