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Value of Fecal Calprotectin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00577928
First Posted: December 20, 2007
Last Update Posted: August 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Indiana University
December 19, 2007
December 20, 2007
August 10, 2015
April 2006
December 2011   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00577928 on ClinicalTrials.gov Archive Site
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Value of Fecal Calprotectin
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
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).
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Observational
Observational Model: Case Control
Time Perspective: Retrospective
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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.
  • Calprotectin
  • Inflammatory Bowel Disease
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  • 1
  • 2
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
December 2011
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Calprotectin assay at IU in last 12 months
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00577928
060362
IRB# 0603-62
No
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Indiana University
Indiana University
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Principal Investigator: Michael Chiorean, M.D. Indiana University
Indiana University
August 2015