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| Name | Class |
|---|---|
| Crohn's and Colitis Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation | Children newly diagnosed with Crohn's disease. |
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| Measure | Description | 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. | 3 years |
| Measure | Description | 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. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Study population will consist of children newly diagnosed with Crohn's disease at primary care clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Subra Kugathasan, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| UCLA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30213581 | Derived | 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. |
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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.
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California at San Francisco | San Francisco | California | 94143 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32256 | United States |
| Emory-Children's Center - Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Children's Center for Digestive Healthcare | Atlanta | Georgia | 30342 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| Riley Children's Hospital - Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| Johns Hopkins Children's Center | Baltimore | Maryland | 21287 | United States |
| Children's Hospital Boston - Harvard Medical School | Boston | Massachusetts | 02115 | United States |
| Goryeb Children's Hospital - Atlantic Health System | Morristown | New Jersey | 07962 | United States |
| The Research Foundation of SUNY on behalf of the University at Buffalo | Buffalo | New York | 14222 | United States |
| Cohens (Schneider) Children's Hospital | New Hyde Park | New York | 11040 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15224 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | United States |
| Children's Medical Center | Dallas | Texas | 75235 | United States |
| BCM Texas Children's Hospital - Houston | Houston | Texas | 77030 | United States |
| Primary Children's Medical Center - University of Utah | Salt Lake City | Utah | 84113 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| IWK Health Centre | Halifax | Nova Scotia | B3K6R8 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| The Hospital for Sick Children - Sickkids | Toronto | Ontario | M5G1X8 | Canada |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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