Expired Study
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Indianapolis, Indiana 46202


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).


Criteria:

Inclusion Criteria: - Calprotectin assay at IU in last 12 months


Study is Available At:


Original ID:

060362


NCT ID:

NCT00577928


Secondary ID:

IRB# 0603-62


Study Acronym:


Brief Title:

Value of Fecal Calprotectin


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Indiana University


Oversight Authority:

United States: Institution Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspectiv


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

171


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael Chiorean, M.D.
Principal Investigator
Indiana University

Study Dates

Start Date:April 2006
Completion Date:December 2011
Completion Type:Actual
Primary Completion Date:December 2011
Primary Completion Type:Actual
Verification Date:August 2015
Last Changed Date:August 7, 2015
First Received Date:December 19, 2007

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:2
Study Arm Type:Other
Arm Name:1

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Indiana University

Samples and Retentions

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.
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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