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

November 12, 2021 updated by: Subra Kugathasan, MD, Emory University

Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children With Crohn's Disease

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

1813

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K6R8
        • IWK Health Centre
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G1X8
        • The Hospital for Sick Children - Sickkids
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • San Francisco, California, United States, 94143
        • University of California at San Francisco
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Nemours Children's Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Children's Center for Digestive Healthcare
      • Atlanta, Georgia, United States, 30322
        • Emory-Children's Center - Emory University School of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Children's Hospital - Indiana University School of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Children's Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston - Harvard Medical School
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Goryeb Children's Hospital - Atlantic Health System
    • New York
      • Buffalo, New York, United States, 14222
        • The Research Foundation of SUNY on behalf of the University at Buffalo
      • New Hyde Park, New York, United States, 11040
        • Cohens (Schneider) Children's Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Monroe Carell Jr. Children's Hospital at Vanderbilt
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Medical Center
      • Houston, Texas, United States, 77030
        • BCM Texas Children's Hospital - Houston
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Medical Center - University of Utah
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 days to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study population will consist of children newly diagnosed with Crohn's disease at primary care clinics.

Description

Inclusion Criteria:

  • Males and females younger than 17 years of age (before their 17th birthday). An upper limit of 17 years of age was selected as important inclusion criteria to maximize the number of potential subjects that would be diagnosed and followed by a pediatric gastroenterologist for at least 3 years.
  • Confirmed or suspected diagnosis of Crohn's disease based on standardized diagnostic criteria. The enrollment should occur within 30 days of diagnosis.
  • Able to provide written informed consent or the ability to obtain written informed consent 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 this clinical trial.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Observation
Children newly diagnosed with Crohn's disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify demographic, clinical, microbial, genetic, and/or immunologic risk factors influencing the likelihood of rapid development of complicated disease phenotypes manifested as penetrating or stricturing disease and need for surgery.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Develop and validate risk stratification by stratifying patients into different levels of risk at diagnosis based on clinical, demographic, host microbial ecology, immune, and genetic determinants.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

Crohn's and Colitis Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

November 12, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Actual)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00012206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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