Risk Stratification of Rapid Disease Progression in Children With Crohn's Disease

Last updated: November 12, 2021
Sponsor: Emory University
Overall Status: Completed

Phase

N/A

Condition

Bowel Dysfunction

Crohn's Disease

Ulcerative Colitis

Treatment

N/A

Clinical Study ID

NCT00790543
IRB00012206
  • Ages < 16
  • All Genders

Study Summary

The purpose of this study for children with a new diagnosis of Crohn's disease is to identify biomarkers found in the blood or stool to help predict which children are at risk of developing complications.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and females younger than 17 years of age (before their 17th birthday). An upperlimit of 17 years of age was selected as important inclusion criteria to maximize thenumber of potential subjects that would be diagnosed and followed by a pediatricgastroenterologist for at least 3 years.
  • Confirmed or suspected diagnosis of Crohn's disease based on standardized diagnosticcriteria. The enrollment should occur within 30 days of diagnosis.
  • Able to provide written informed consent or the ability to obtain written informedconsent from the parents or patient's legal guardian in conjunction with youth assent.
  • Consented to have specimens tested for genetics and immune responses.
  • Access to follow-up data for a minimum of 36 months after diagnosis.
  • Final eligibility will be determined by the health professionals conducting thisclinical trial.

Exclusion

Exclusion Criteria:

  • Infectious colitis.
  • Final eligibility will be determined by the health professionals conducting thisclinical trial.

Study Design

Total Participants: 1813
Study Start date:
November 01, 2008
Estimated Completion Date:
December 31, 2020

Study Description

It is estimated that between 15-20% of children with Crohn's disease will develop complications that can require surgery within the first three years of diagnosis. The purpose of this study for children with a new diagnosis of Crohn's disease is to identify biomarkers found in the blood or stool to help predict which children are at risk of developing complications.

A total of 2000 children with newly-diagnosed Crohn's disease will be enrolled within 30 days of diagnosis. Up to 28 medical sites in the United States and Canada will participate in the study.

Connect with a study center

  • IWK Health Centre

    Halifax, Nova Scotia B3K6R8
    Canada

    Site Not Available

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario K1H 8L1
    Canada

    Site Not Available

  • The Hospital for Sick Children - Sickkids

    Toronto, Ontario M5G1X8
    Canada

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • UCLA Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California at San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • The Children's Hospital and University of Colorado, Denver

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Nemours Children's Clinic

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Children's Center for Digestive Healthcare

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Emory-Children's Center - Emory University School of Medicine

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • The University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Riley Children's Hospital - Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Johns Hopkins Children's Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Children's Hospital Boston - Harvard Medical School

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Goryeb Children's Hospital - Atlantic Health System

    Morristown, New Jersey 07962
    United States

    Site Not Available

  • The Research Foundation of SUNY on behalf of the University at Buffalo

    Buffalo, New York 14222
    United States

    Site Not Available

  • Cohens (Schneider) Children's Hospital

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Children's Medical Center

    Dallas, Texas 75235
    United States

    Site Not Available

  • BCM Texas Children's Hospital - Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Primary Children's Medical Center - University of Utah

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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