- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00577928
Value of Fecal Calprotectin
August 7, 2015 updated by: Indiana University
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).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
171
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
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.
Description
Inclusion Criteria:
- Calprotectin assay at IU in last 12 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
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2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Chiorean, M.D., Indiana University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
December 19, 2007
First Submitted That Met QC Criteria
December 19, 2007
First Posted (Estimate)
December 20, 2007
Study Record Updates
Last Update Posted (Estimate)
August 10, 2015
Last Update Submitted That Met QC Criteria
August 7, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 060362
- IRB# 0603-62
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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