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| Name | Class |
|---|---|
| Crohn's and Colitis Foundation | OTHER |
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A multi-center observational study based at referral centers and community hospitals within the US. Patients' blood will be collected at enrollment for testing with PredictSURE IBDâ„¢, which will occur at a later date. Patients will be prospectively followed up for 12 months with clinicians treating according to local standard of care, with a step-up or accelerated step-up regimen. Clinicians and patients will be blinded to the biomarker results.
This is a multi-center, observational study of newly diagnosed IBD (CD or UC) patients. The Study aims to assess whether a prognostic biomarker can stratify IBD patients in the US.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PredictSURE IBDâ„¢ | Other | To evaluate a test called PredictSURE IBDâ„¢ in the US population |
| Measure | Description | Time Frame |
|---|---|---|
| To stratify patients at diagnosis into high and low- risk cohorts | Stratifying patients into high or low risk of following an aggressive disease course requiring frequent treatment escalations. | 12 month follow up |
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Inclusion Criteria:
Note, the ideal patients for this study are newly diagnosed patients who are treatment-naïve.
Exclusion Criteria:
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The target patient populations are newly diagnosed, active CD or UC in patients who are immunomodulator and anti-TNFα treatment naïve.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Hills, PhD | Contact | +44 (0) 1223 804195 | khills@predictimmune.com |
| Name | Affiliation | Role |
|---|---|---|
| James Lee, MD | PredictImmune Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Crohn's and Colitis Center | Recruiting | Miami | Florida | 33136 | United States |
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Following patient consent and recruitment to the study, a 2.5 ml blood sample will be collected in a PAXgene tube.
| Washington University in St. Louis | Recruiting | St Louis | Missouri | 63130 | United States |
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| Rutgers Robert Wood Johnson Medical School (Adult) | Recruiting | New Brunswick | New Jersey | 08901 | United States |
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| Rutgers Robert Wood Johnson Medical School (Prediatric) | Recruiting | New Brunswick | New Jersey | 08901 | United States |
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| Manhattan Clinical Research, LLC. | Recruiting | New York | New York | 10016 | United States |
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| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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| Weill Cornell Medical Center | Recruiting | New York | New York | 10065 | United States |
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| ClinSearch | Recruiting | Chattanooga | Tennessee | 37421 | United States |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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