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TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.
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| Measure | Description | Time Frame |
|---|---|---|
| Natural history of Inflammatory Bowel Disease: Characteristics of IBD | Up to 5 years | |
| Natural history of Inflammatory Bowel Disease: Participant demographics | Up to 5 years | |
| Natural history of Inflammatory Bowel Disease: Treatment use | Up to 5 years | |
| Natural history of Inflammatory Bowel Disease: Treatment response | Up to 5 years | |
| Natural history of Inflammatory Bowel Disease: Disease progression | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic measures of mucosal healing | Up to 5 years | |
| Adverse event frequency and severity | Every 3 months for 5 years | |
| Timepoint of clinical response |
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Inclusion Criteria:
Exclusion Criteria:
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Adults and children (age 2 or older) with a diagnosis of Crohn's disease, Ulcerative colitis, or Indeterminate colitis having been prescribed any IBD treatment outside of a clinical trial
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Om Research | Lancaster | California | 93534 | United States | ||
| FACEY Medical Foundation |
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Patients enrolled in TARGET-IBD may be invited to participate in the Biorepository Bank (BSB). Blood samples for biomarker and DNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study. These samples will be shipped to a central repository for storage to use in future studies. Samples stored at the biorepository will be identified only with the participant's unique study ID number and the date the sample was obtained. The link between the participant's study ID number and their name will be available only at the site where the samples were obtained.
| Every 3 months for 5 years |
| Timepoint of endoscopic response | Up to 5 years |
| Reasons for treatment discontinuation | Up to 5 years |
| Self-reported patient health measures: EQ-5D | Every 3 months for 5 years |
| Self-reported patient health measures: PRO-2 for Crohn's Disease | Every 3 months for 5 years |
| Self-reported patient health measures: PRO-2 for Ulcerative colitis | Every 3 months for 5 years |
| Self-reported patient health measures: 2-question Adherence Measure | Every 3 months for 5 years |
| Self-reported patient health measures: Manitoba IBD Index (MIBDI) | Every 3 months for 5 years |
| Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI) | Every 3 months for 5 years |
| Timepoint of endoscopic remission | Up to 5 years |
| Mission Hills |
| California |
| 91345 |
| United States |
| University of California - Davis | Sacramento | California | 95817 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| Gastro Florida | Clearwater | Florida | 33762 | United States |
| University of Florida Health Jacksonville-Gastroenterology | Jacksonville | Florida | 32207 | United States |
| Advanced Gastroenterology Associates, LLC | Palm Harbor | Florida | 34684 | United States |
| Atlanta Gastro | Atlanta | Georgia | 30342 | United States |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | 46237 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Gastroenterology Associates | Baton Rouge | Louisiana | 70809 | United States |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
| Saint Louis University | St Louis | Missouri | 63104 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03755 | United States |
| Rutgers, Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Mount Sinai, Icahn School of Medicine | New York | New York | 10029 | United States |
| Premier Medical Group of the Hudson Valley | Poughkeepsie | New York | 12601 | United States |
| The Children's Hospital at Montefiore | The Bronx | New York | 10467 | United States |
| Cary Gastroenterology Associates | Cary | North Carolina | 27518 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Healthcare System-Center for Digestive Health | Charlotte | North Carolina | 28204 | United States |
| Digestive Health Specialists, PA | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic/DIgestive Disease and Surgery Institute | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| MultiCare Institute for Research and Innovation | Tacoma | Washington | 98405 | United States |
| University of Wisconsin Hospital & Clinics | Madison | Wisconsin | 53705 | United States |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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