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

• ClinicalTrials.gov Identifier: NCT00790543
• Recruitment Status: Active, not recruiting
• First Posted: November 13, 2008
• Last Update Posted: July 23, 2020
• Sponsor: Emory University
• Collaborator: Crohn's and Colitis Foundation
• Information provided by (Responsible Party): Subra Kugathasan, MD, Emory University

Tracking Information

• First Submitted Date: November 12, 2008
• First Posted Date: November 13, 2008
• Last Update Posted Date: July 23, 2020
• Study Start Date: November 2008
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 12, 2008): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: November 12, 2008): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Risk Stratification of Rapid Disease Progression in Children With Crohn's Disease
• Official Title: Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children With Crohn's Disease
• Brief 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.

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
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

At time of enrollment, whole blood for DNA and serum will be collected in all patients. Fresh fecal samples will also be requested. For gene expression analysis, biopsy specimens will be collected during regularly scheduled endoscopies.

• Sampling Method: Probability Sample
• Study Population: Study population will consist of children newly diagnosed with Crohn's disease at primary care clinics.
• Condition: Crohn's Disease
• Intervention: Not Provided

Study Groups/Cohorts

Observation

Children newly diagnosed with Crohn's disease.

• Publications *: Ballengee CR, Stidham RW, Liu C, Kim MO, Prince J, Mondal K, Baldassano R, Dubinsky M, Markowitz J, Leleiko N, Hyams J, Denson L, Kugathasan S. Association Between Plasma Level of Collagen Type III Alpha 1 Chain and Development of Strictures in Pediatric Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1799-1806. doi: 10.1016/j.cgh.2018.09.008. Epub 2018 Sep 10.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 22, 2020): 1813
• Original Estimated Enrollment (submitted: November 12, 2008): 1000
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 16 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT00790543
• Other Study ID Numbers: IRB00012206
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Subra Kugathasan, MD, Emory University
• Study Sponsor: Emory University
• Collaborators: Crohn's and Colitis Foundation

Investigators

• Principal Investigator: Subra Kugathasan, MD; Emory University

• PRS Account: Emory University
• Verification Date: July 2020