FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of Inflammatory Bowel Disease (IBD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01676324
First received: August 28, 2012
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

Hypothesis:

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.

Objectives:

By means of a survey from the ordering physician we would assess:

Primary Endpoint

1. The Percentage of time that the Fecal Calprotectin result caused the physician to change the management of a patient.

Secondary Endpoints

  1. To determine if the Fecal Calprotectin result influenced the number of endoscopies performed
  2. To correlate how well the Fecal Calprotectin correlates with Endoscopic findings when endoscopy was performed.
  3. 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
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of IBD

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Percentage of time that Fecal Calprotectin result caused the physician to change the management of a patient. [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Enrollment: 289
Study Start Date: September 2012
Study Completion Date: September 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Inflammatory Bowel Disease
Those with Inflammatory Bowel Disease (known) and those with no Inflammatory Bowel Disease (not previously diagnosed)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be those age 19 or older seen by community and academic gastroenterologists and may be referred for Fecal Calprotectin testing at the discretion of the Gastroenterologist.

Criteria

Inclusion Criteria:

  • Subjects must be at least 19 years of age or older, they must be able to read and provide written consent in English.

Subjects will have gastrointestinal symptoms or be known to have Inflammatory Bowel Disease whereby the clinician feels that obtaining Fecal Calprotectin may be useful in the care of the patient. Patients must be able to collect a feces sample and return it for analysis within 3 days

Exclusion Criteria:

  • Known Ischemic colitis, infectious enteritis or colitis, known colorectal cancer, history of extensive bowel resection, ostomy, current daily use of NSAIDs (aspirin, ibuprofen, naproxen, etc) or the inability to collect sample and return it within 3 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676324

Locations
Canada, British Columbia
GI Research Institute (GIRI)
Vancouver, British Columbia, Canada, V6Z 2K5
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Brian Bressler, MD Department of Medicine, Division of Gastroenterology, UBC
  More Information

Publications:
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01676324     History of Changes
Other Study ID Numbers: H12-01499
Study First Received: August 28, 2012
Last Updated: June 5, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Fecal Calprotectin

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014