NCT00833170

Brief 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. The project follows these children quarterly from diagnosis examining clinical, laboratory, and humanistic outcomes. Genetic and serologic monitoring is performed on the study population.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
2 countries

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2002

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

12.3 years

First QC Date

January 28, 2009

Last Update Submit

February 15, 2019

Conditions

Keywords

pediatric inflammatory bowel diseasemultiple site study

Outcome Measures

Primary Outcomes (1)

  • Clinical activity following biologic and immunomodulatory therapy

    Clinical Outcomes

    10 years

Eligibility Criteria

Age1 Month - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children \<16 years old with inflammatory bowel disease

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Childrens Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207-8426, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

James Whitcomb Riley Hospital for Children

Indianapolis, Indiana, 46202-5225, United States

Location

The John's Hopkins Medical Institute

Baltimore, Maryland, 21287-2631, United States

Location

Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

Steven & Alexandra Cohen Children's Medical Center

New Hyde Park, New York, 11040, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794-8111, United States

Location

Children's Hospital At Montefiore

The Bronx, New York, 10467, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Dayton Children's Medical Center

Dayton, Ohio, 45404-1898, United States

Location

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

The Children's Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

IWK Health Centre,

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

CHU Sainte-Justine Hospital

Montreal, Quebec, H3T IC5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Jeffrey S. Hyams, M.D.

    Connecticut Children's Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 30, 2009

Study Start

January 28, 2002

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 18, 2019

Record last verified: 2019-02

Locations