Inflammatory Bowel DiseaseNCT00833170
Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry
An observational study of Inflammatory Bowel Disease, run by Connecticut Children's Medical Center at 28 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Inflammatory Bowel Disease
- How many people
- 1,600 participants
- Where
- 28 sitesin 2 countries
- Study dates
- 28 Jan 2002to 1 Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children <16 years old with inflammatory bowel disease
Who may be able to join
- Definite diagnosis of ulcerative colitis, Crohn's disease, indeterminate colitis
- Age up to 16 years and zero days at time of diagnosis
- Informed consent/assent from parent/guardian and patient
- Ability to be available for regular follow-up visits
Who cannot join
- Diagnosis of IBD greater than 1 month prior to presentation to participating center
- Age greater than 16 years and zero days
- Inability to be available for regular follow-up visits
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States24 sites
Emory University
Atlanta, Georgia, 30322
The John's Hopkins Medical Institute
Baltimore, Maryland, 21287-2631
University of Alabama
Birmingham, Alabama, 35233
Children's Hospital
Boston, Massachusetts, 02115
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Nationwide Children's Hospital
Columbus, Ohio, 43205
Dayton Children's Medical Center
Dayton, Ohio, 45404-1898
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Hershey Medical Center
Hershey, Pennsylvania, 17033
James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, 46202-5225
Nemours Children's Clinic
Jacksonville, Florida, 32207-8426
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Morristown Memorial Hospital
Morristown, New Jersey, 07962
Steven & Alexandra Cohen Children's Medical Center
New Hyde Park, New York, 11040
The Children's Hospital
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Rhode Island Hospital
Providence, Rhode Island, 02903
Mayo Clinic
Rochester, Minnesota, 55905
Stony Brook University Hospital
Stony Brook, New York, 11794-8111
Children's Hospital At Montefiore
The Bronx, New York, 10467
Childrens Hospital
Washington D.C., District of Columbia, 20010
Canada4 sites
IWK Health Centre,
Halifax, Nova Scotia, B3K 6R8
CHU Sainte-Justine Hospital
Montreal, Quebec, H3T IC5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
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.
Read the 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.
- Conditions
- Inflammatory Bowel Disease
- Keywords
- pediatric inflammatory bowel disease, multiple site study
- Medical subject headings
- Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical activity following biologic and immunomodulatory therapy
Clinical Outcomes
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study start28 Jan 2002
- Primary completion1 Jun 2014
- Study completion1 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor, Inc.
- Responsible party
- Principal investigator, Jeffrey Hyams, MD, Connecticut Children's Medical Center
- Investigators
- Jeffrey S. Hyams, M.D., Principal investigator, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833170
- Sponsor's protocol ID
- PIBDCRG1
- Status last verified
- Feb 2019
- First submitted
- 28 Jan 2009
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry
- ClinicalTrials.gov ID
- NCT00833170
- Acronym / sponsor ID
- PIBDCRG1
- Conditions
- Inflammatory Bowel Disease
- Keywords
- pediatric inflammatory bowel disease, multiple site study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Collaborators
- Centocor, Inc.
- Study start
- 28 Jan 2002 (actual)
- Primary completion
- 1 Jun 2014 (actual)
- Study completion
- 1 Jun 2014 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children <16 years old with inflammatory bowel disease
Key inclusion criteria (4 listed)
- Definite diagnosis of ulcerative colitis, Crohn's disease, indeterminate colitis
- Age up to 16 years and zero days at time of diagnosis
- Informed consent/assent from parent/guardian and patient
- Ability to be available for regular follow-up visits
Key exclusion criteria (3 listed)
- Diagnosis of IBD greater than 1 month prior to presentation to participating center
- Age greater than 16 years and zero days
- Inability to be available for regular follow-up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical activity following biologic and immunomodulatory therapy
Time frame: 10 years
Clinical Outcomes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey S. Hyams, M.D. principal investigator
Connecticut Children's Medical Center
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by Connecticut Children's Medical Center at 28 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical activity following biologic and immunomodulatory therapy (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.