Crohn's DiseaseRSNCT00790543
Risk Stratification of Rapid Disease Progression in Children With Crohn's Disease
An observational study of Crohn's Disease, run by Emory University at 28 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 days to 16 years
- Conditions the study is for
- Crohn's Disease
- How many people
- 1,813 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Nov 2008to 31 Dec 2020
- 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 5 days to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Study population will consist of children newly diagnosed with Crohn's disease at primary care clinics.
Who may be able to join
- 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.
Who cannot join
- Infectious colitis.
- Final eligibility will be determined by the health professionals conducting this clinical trial.
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States25 sites
Emory-Children's Center - Emory University School of Medicine
Atlanta, Georgia, 30322
Children's Center for Digestive Healthcare
Atlanta, Georgia, 30342
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
Children's Hospital Boston - Harvard Medical School
Boston, Massachusetts, 02115
The Research Foundation of SUNY on behalf of the University at Buffalo
Buffalo, New York, 14222
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
The University of Chicago
Chicago, Illinois, 60637
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Children's Medical Center
Dallas, Texas, 75235
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
BCM Texas Children's Hospital - Houston
Houston, Texas, 77030
Riley Children's Hospital - Indiana University School of Medicine
Indianapolis, Indiana, 46202
Nemours Children's Clinic
Jacksonville, Florida, 32256
Cedars-Sinai Medical Center
Los Angeles, California, 90048
UCLA Medical Center
Los Angeles, California, 90095
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Goryeb Children's Hospital - Atlantic Health System
Morristown, New Jersey, 07962
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Cohens (Schneider) Children's Hospital
New Hyde Park, New York, 11040
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224
Rhode Island Hospital
Providence, Rhode Island, 02903
Primary Children's Medical Center - University of Utah
Salt Lake City, Utah, 84113
University of California at San Francisco
San Francisco, California, 94143
Canada3 sites
IWK Health Centre
Halifax, Nova Scotia, B3K6R8
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Hospital for Sick Children - Sickkids
Toronto, Ontario, M5G1X8
About this study
Official title: 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.
Read the 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.
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Inflammatory Bowel Disease
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Children newly diagnosed with Crohn's disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startNov 2008
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- 1,813 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Responsible party
- Principal investigator, Subra Kugathasan, MD, Emory University
- Investigators
- Subra Kugathasan, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790543
- Sponsor's protocol ID
- IRB00012206
- Acronym
- RS
- Status last verified
- Nov 2021
- First submitted
- 12 Nov 2008
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 30213581
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children With Crohn's Disease
- ClinicalTrials.gov ID
- NCT00790543
- Acronym / sponsor ID
- RS / IRB00012206
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,813 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Study start
- Nov 2008
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Nov 2008 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Children newly diagnosed with Crohn's disease. |
Who may qualify
- Ages
- 5 days to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Study population will consist of children newly diagnosed with Crohn's disease at primary care clinics.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Infectious colitis.
- Final eligibility will be determined by the health professionals conducting this clinical trial.
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
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
1 secondary outcome
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
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 16 Nov 2021.
- Derived from this study: PubMed 30213581Ballengee 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.
- Individual participant dataSharing planned: No
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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.
Subra Kugathasan, MD principal investigator
Emory University
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 Crohn's Disease, run by Emory University 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 6 inclusion and 2 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 16 Nov 2021. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00790543, which also lists 1 linked publication.
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 16 Nov 2021.