Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry

Condition(s) targeted: Inflammatory Bowel Disease

Phase: N/A

Status: Recruiting

Sponsored by: Connecticut Children's Medical Center

Official(s) and/or principal investigator(s):
Jeffrey S. Hyams, M.D., Principal Investigator, Affiliation: Connecticut Children's Medical Center

Overall contact:
Jeffrey S. Hyams, M.D., Phone: (860)545-9565, Email: jhyams@ccmckids.org

The purpose of the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry is to study the contemporary natural history of children <16 years of age newly diagnosed with inflammatory bowel disease. The project follows these children quarterly from diagnosis examining clinical, laboratory, and humanistic outcomes. Genetic and serologic monitoring is performed on the study population.

Official title: Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry

Study design: Cohort, Prospective

Primary outcome: Clinical activity following biologic and immunomodulatory therapy

Detailed description: Observations of children with IBD often suggest a more severe course than that found in adults. Explanations for this are unclear, especially since children are less likely to engage in some behaviors (e. g., smoking) that may have a deleterious effect on disease course as noted in adults. In many ways children are a better "experimental model" of IBD because they don't have as many confounding medical factors as adults. Both Crohn's disease and ulcerative colitis are believed to result from a complex interaction of genetic and environmental factors (1). Recently, the gene CARD15/NOD2 on chromosome 16 has been identified in approximately 25% of Caucasian patients with Crohn's disease and is felt to be a significant predisposing factor to the development of fibrostenosing disease (2). Additionally, seropositivity for perinuclear antinuclear cytoplasmic factor (pANCA) has been demonstrated much more frequently in patients with ulcerative colitis than in those with Crohn's disease, while anti-Saccharomyces antibody (ASCA) is more common in the latter population (3). The importance of these serological abnormalities is not clear, though some data suggest an influence on the development of complications.

Our hypothesis is that phenotypic, genotypic and serologic characteristics may provide prognostic information on response to therapy and course in children with IBD. This type of prognostic information is particularly important as newer therapies are developed.

Minimum age: 1 Month. Maximum age: 16 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Definite diagnosis of ulcerative colitis, Crohn's disease, indeterminate colitis

2. Age up to 16 years and zero days at time of diagnosis

3. Informed consent/assent from parent/guardian and patient

4. Ability to be available for regular follow-up visits

Exclusion Criteria:

1. Diagnosis of IBD greater than 1 month prior to presentation to participating center

2. Age greater than 16 years and zero days

3. Inability to be available for regular follow-up visits

Jeffrey S. Hyams, M.D., Phone: (860)545-9565, Email: jhyams@ccmckids.org

University of Alabama, Birmingham, Alabama 35233, United States; Recruiting
Cindy Atkins, Phone: 205-939-5843, Email: catkins@peds.uab.edu

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States; Recruiting
Miriam Lincoln, Phone: 860-545-9540, Email: mlincoln@ccmckids.org

Childrens Hospital, Washington, District of Columbia 20010, United States; Recruiting
Allegra Gary, Phone: 202-476-3058, Email: agary@cnmc.org

Nemours Children's Clinic, Jacksonville, Florida 32207-8426, United States; Recruiting
Shari Huffman, Phone: 904-390-3501, Email: shuffman@nemours.org

James Whitcomb Riley Hospital for Children, Indianapolis, Indiana 46202-5225, United States; Recruiting
Gail Waltz, Phone: 317-274-9656, Email: gwaltz@iupui.edu

The John's Hopkins Medical Institute,, Baltimore, Maryland 21287-2631, United States; Recruiting
Vivian Abadom, Phone: 410-955-0779, Email: vabadom1@jhmi.edu

Children's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Lori Ann Ashworth, Phone: 617-355-2963, Email: Lori.Ashworth@childrens.harvard.edu

Morristown Memorial Hospital, Morristown, New Jersey 07962, United States; Recruiting
Ruth Irizarry, Phone: 973-971-7591, Email: Ruth.Irizarry@atlantichealth.org

Schneider Children's Hospital, New Hyde Park, New York 11040, United States; Recruiting
Kathleen Grancher, Phone: 718-470-3363, Email: kgranche@nshs.edu

University of North Carolina, Chapel Hill, North Carolina 27599, United States; Recruiting
Katie McLean, Phone: 919-928-3255, Email: kamclean@med.unc.edu

IWK Health Centre,, Halifax, Nova Scotia B3K 6R8, Canada; Recruiting
Barbara Christensen, Phone: 902-470-7009, Email: Barbara.Christensen@IWK.NSHEALTH.CA

Children's Medical Center, Dayton, Ohio 45404-1898, United States; Recruiting
Myrna Miller, Phone: 937-641-4515, Email: millermj@childrensdayton.org

The Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States; Recruiting
Kelley Koslasky, Phone: 216-444-2237, Email: koslask@ccf.org

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States; Recruiting
Kelly Boyer, Phone: 513-636-8160, Email: Kelly.Boyer@cchmc.org

Nationwide Children's Hospital, Columbus, Ohio 43205, United States; Recruiting
Melissa Metheney, Phone: 614-722-2266, Email: Melissa.Metheney@nationwidechildrens.org

Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Recruiting
Karen Frost, Phone: 416-813-5633, Email: karen.frost@sickkids.ca

Children's Hospital of Eastern Ontario, Ottawa, Ontario K1H 8L1, Canada; Recruiting
Ruth Singleton, Phone: 613-737-2516, Email: rsingleton@cheo.on.ca

The Children's Hospital,, Philadelphia, Pennsylvania 19104, United States; Recruiting
Daniel Latta, Phone: 215-590-2359, Email: LattaD@email.chop.edu

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Sandra McRandal, Phone: 412-692-8453, Email: sandra.mcrandal@chp.edu

Rhode Island Hospital,, Providence, Rhode Island 02903, United States; Recruiting
Barbara Bancroft, Phone: 401-444-2884, Email: Bbancroft@lifespan.org

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States; Recruiting
Paola Duran, Phone: 414-266-7273, Email: pduran@mcw.edu

Starting date: January 2002
Ending date: January 2015
Last updated: January 28, 2009