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| Sponsored by: |
Indiana University |
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00577928 |
Purpose
For the main goal - the accuracy of calprotectin for the diagnosis of IBD - calprotectin levels will be compared between patients with and without a diagnosis of IBD and the sensitivity, specificity and accuracy will be determined. For the secondary aim - the correlation between calprotectin levels and disease activity - in patients with IBD selected from this cohort, we will determine the association between calprotectin levels and clinical IBD score, serological markers (WBC, Hgb, Platelets, ESR, CRP, Albumin), endoscopic (disease score, pathological activity) and radiological features (bowel wall thickening, enhancement, edema, mesenteric inflammation).
| Condition |
|
Calprotectin Inflammatory Bowel Disease |
| Genetics Home Reference related topics: | Crohn disease |
| MedlinePlus related topics: | Endoscopy |
| Study Type: | Observational |
| Study Design: | Case Control, Retrospective |
| Official Title: | Correlation of Fecal Calprotectin Level With the Clinical, Endoscopic, Histologic and Radiologic Activity in Inflammatory Bowel diseaseThe Value of Fecal Calprotectin for the Diagnosis and Assessment of Inflammatory Bowel Disease |
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | December 2007 |
| Groups/Cohorts |
| 1 |
| 2 |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
All patients who had calprotectin assays as part of their evaluations for lower gastrointestinal symptoms in the Division of Gastroenterology at IU within the last 12 months will be considered eligible for the study.
Inclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Indiana University ( Michael Chiorean, M.D. ) |
| Study ID Numbers: | 060362, IRB# 0603-62 |
| First Received: | December 19, 2007 |
| Last Updated: | December 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00577928 |
| Health Authority: | United States: Institution Review Board |
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