FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of Inflammatory Bowel Disease (IBD) (FOCUS)
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|ClinicalTrials.gov Identifier: NCT01676324|
Recruitment Status : Completed
First Posted : August 30, 2012
Last Update Posted : June 9, 2014
Fecal Calprotectin will be useful in guiding the diagnosis and management of patients with Inflammatory Bowel Disease. Fecal Calprotectin can be utilized as an alternative to colonoscopy in the management of patients with Inflammatory Bowel Disease.
By means of a survey from the ordering physician we would assess:
1. The Percentage of time that the Fecal Calprotectin result caused the physician to change the management of a patient.
- To determine if the Fecal Calprotectin result influenced the number of endoscopies performed
- To correlate how well the Fecal Calprotectin correlates with Endoscopic findings when endoscopy was performed.
- To assess the correlation between the Fecal Calprotectin level and symptoms as measured by the Harvey Bradshaw index or the partial Mayo Score (or full Mayo Score depending if endoscopy was performed).
|Condition or disease|
|Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis|
Patients will be identified as eligible by the attending Gastroenterologist during the course of a usual consultation. Patients will be referred to the research nurse in the doctor's office for further information regarding the study and informed consent will be obtained by the research nurse.
Upon enrollment, the physician or the research nurse will complete an online requisition form with a unique code which will provide the baseline data. The patient will be provided with the Easy Sampler™ collection kit and instructions on the use of this kit and location on where to send the specimen.
The nurse will then send an email to the research nurse in the originating physician's office with the result of the calprotectin assay. The research nurse will review the result with the physician. After physician review, either the physician or the research nurse will then complete a follow up survey online.
After completion of the assays and surveys, the data will be tabulated electronically from the online website and analyzed by the PI and/or co-investigators.
|Study Type :||Observational|
|Actual Enrollment :||289 participants|
|Official Title:||FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of IBD|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||September 2013|
Inflammatory Bowel Disease
Those with Inflammatory Bowel Disease (known) and those with no Inflammatory Bowel Disease (not previously diagnosed)
- Percentage of time that Fecal Calprotectin result caused the physician to change the management of a patient. [ Time Frame: one year ]The utility of the test will be assessed by comparing the proportion of time the test altered management for each of the two groups (IBD present vs. IBD absent). The groups will be compared using paired t-tests and McNemar's test as appropriate. Multivariate analysis will be used to assess the impact of the baseline variables on the test utility.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676324
|Canada, British Columbia|
|GI Research Institute (GIRI)|
|Vancouver, British Columbia, Canada, V6Z 2K5|
|Principal Investigator:||Brian Bressler, MD||Department of Medicine, Division of Gastroenterology, UBC|