Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Connecticut Children's Medical Center
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Jeffrey Hyams, MD, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT00833170
First received: January 28, 2009
Last updated: March 13, 2014
Last verified: January 2014
  Purpose

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.


Condition
Inflammatory Bowel Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry

Further study details as provided by Connecticut Children's Medical Center:

Primary Outcome Measures:
  • Clinical activity following biologic and immunomodulatory therapy [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Estimated Enrollment: 1000
Study Start Date: January 2002
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Month to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children <16 years old with inflammatory bowel disease

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833170

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

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Terminated
Birmingham, Alabama, United States, 35233
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Marina Fernandez    860-545-8125    mfernandez@ccmckids.org   
Principal Investigator: Jeffrey S. Hyams, M.D.         
United States, District of Columbia
Childrens Hospital Terminated
Washington, District of Columbia, United States, 20010
United States, Florida
Nemours Children's Clinic Terminated
Jacksonville, Florida, United States, 32207-8426
United States, Georgia
Emory University Active, not recruiting
Atlanta, Georgia, United States, 30322
United States, Indiana
James Whitcomb Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202-5225
Contact: Gail Waltz    317-274-9656    gwaltz@iupui.edu   
Principal Investigator: Marian Pfefferkorn, M.D.         
United States, Maryland
The John's Hopkins Medical Institute Recruiting
Baltimore, Maryland, United States, 21287-2631
Contact: Vivian Abadom    410-955-0779    vabadom1@jhmi.edu   
Principal Investigator: Maria Oliva-Hemker, M.D.         
United States, Massachusetts
Children's Hospital Terminated
Boston, Massachusetts, United States, 02115
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Shannon Riggs    612-625-2422    Riggs049@umn.edu   
Principal Investigator: Boris Sudel, M.D.         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jessica Augustin    507-266-9917    augustin.jessica@mayo.edu   
Principal Investigator: William Faubion, M.D.         
United States, New Jersey
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Annette Langseder    973-971-7747    Annette.Langseder@atlantichealth.or   
Principal Investigator: Joel Rosh, M.D.         
United States, New York
Children's Hospital At Montefiore Recruiting
Bronx, New York, United States, 10467
Contact: Gaelle Erisnor    718-741-2557    gerisnor@montefiore.org   
Principal Investigator: Gitit Tomer, MD         
Steven & Alexandra Cohen Children's Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Dianne Bachan    516-472-3692    Dbachan@mshs.edu   
Principal Investigator: James Markowitz, M.D.         
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794-8111
Contact: Katherine Markarian    631-444-3868    Katherine.Askinazi@stonybrook.edu   
Principal Investigator: Jeffery Morganstern, MD         
United States, North Carolina
UNC Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Mary Lewis    919-843-9547    mqlewis@med.unc.edu   
Principal Investigator: Michael Kappelman, M.D.         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Kelly Boyer    513-636-8160    Kelly.Boyer@cchmc.org   
Principal Investigator: Shehzad Saeed, M.D.         
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Kelley Koslasky    216-444-2237    koslask@ccf.org   
Principal Investigator: Marsha Kay, M.D.         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Beth Skaggs    614-722-3487    beth.skaggs@nationwidechildrens.org   
Principal Investigator: Ryan Carvalho, M.D.         
Dayton Children's Medical Center Recruiting
Dayton, Ohio, United States, 45404-1898
Contact: Lisa Reynolds    937-641-4515    reynoldsl@childrensdayton.org   
Principal Investigator: James Rick, M.D.         
United States, Pennsylvania
Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Patricia Carper    717-531-7762    pcarper@hmc.psu.edu   
Principal Investigator: Marc Schaeffer, M.D.         
The Children's Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Theresa Kerbowski    215-426-7765    Kerbowskit@email.chop.edu   
Principal Investigator: Andrew Grossman, M.D.         
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Donna Smith    412-692-6092    smithdd@upmc.edu   
Principal Investigator: David Keljo, M.D.         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Barbara Bancroft    401-444-2884    Bbancroft@lifespan.org   
Principal Investigator: Neal LeLeiko, M.D.         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Christina Gorges    414-266-6131    cgorges@mcw.edu   
Principal Investigator: Jose Cabrera, M.D.         
Canada, Nova Scotia
IWK Health Centre, Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Brad MacIntyre    902-470-7009    brad.macintyre@iwk.nshealth.ca   
Principal Investigator: Anthony Otley, M.D.         
Canada, Ontario
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Ruth Singleton    613-737-2516    rsingleton@cheo.on.ca   
Principal Investigator: David Mack, M.D.         
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Karen Frost    416-813-5633    karen.frost@sickkids.ca   
Principal Investigator: Anne Griffiths, M.D.         
Canada, Quebec
CHU Sainte-Justine Hospital Recruiting
Montreal, Quebec, Canada, H3T IC5
Contact: Catherine Lamoureux    514-345-4931    Catherine.Lamoureux@recherche-ste-justine.qc.ca   
Principal Investigator: Colette Deslandres, MD         
Sponsors and Collaborators
Connecticut Children's Medical Center
Centocor, Inc.
Investigators
Principal Investigator: Jeffrey S. Hyams, M.D. Connecticut Children's Medical Center
  More Information

No publications provided

Responsible Party: Jeffrey Hyams, MD, Study Principal Investigator, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT00833170     History of Changes
Other Study ID Numbers: PIBDCRG1
Study First Received: January 28, 2009
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Connecticut Children's Medical Center:
pediatric inflammatory bowel disease
multiple site study

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on September 29, 2014