- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03408249
IBDoc® Canadian User Performance Evaluation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The patient will determine the calprotectin concentration in their own stool sample using the IBDoc® assay. For this, the patient will collect a stool sample in a standard collection tube at home. The patients will return to the clinical site with the specimen, where they will receive a standardized IBDoc® training. They will also be given opportunity to perform an IBDoc® practice test using the collected sample. The patients will then perform the full IBDoc® assay using the collected stool sample under the observation of the healthcare provider, who will assess their performance. The final result - the interpretation of the IBDoc® lateral flow assay by the CalApp® smartphone application, to yield a final μg/g calprotectin concentration in stool, will be sent to the health care provider (HCP) via the IBDoc® Web Portal.
The usability of the IBDoc® test will be evaluated according to the following factors:
- Trueness/ accuracy - the patients' ability to obtain correct results will be evaluated by comparing patients' IBDoc® results with reference measurements from the same stool sample using the BÜHLMANN fCAL® ELISA, performed at a laboratory site. For reference measurements the HCP at the clinical site will obtain 3 CALEX® Cap extracts from the patient's stool sample, which will be stored frozen and shipped to the laboratory site.
To exclude bias or inaccuracy that may arise from the analytical performance characteristics of the IBDoc® assay itself, a comparative IBDoc® assay will be performed according to the instructions for use, with the patients' samples in a laboratory. For the comparative IBDoc® measurement the HCP at the clinical site will obtain one CALEX® Valve extract from the patient's stool sample, which will be stored frozen and shipped to the laboratory site.
-IBDoc® Calprotectin test usability, clearness of obtained result, and comprehensiveness of the Instruction for Use will be assessed in the following ways:
- Patient's questionnaire
- HCP's questionnaire - human factors evaluation
The ability of patients to correctly collect and extract stool samples using the CALEX® Valve device will be analysed as an additional module within the IBDoc® User Performance Evaluation. The CALEX® Valve extracts obtained by the patients as part of the IBDoc® procedure will be stored frozen and shipped to the laboratory site. Calprotectin levels in the patients' CALEX® Valve extracts will be determined with the BÜHLMANN fCAL® ELISA and compared to calprotectin reference values obtained from the same stool samples by the HCP's.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2R7
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine University of Alberta,
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6Z 2K5
- GIRI (GI Research Institute)
-
-
Quebec
-
Lévis, Quebec, Canada
- Hôtel-Dieu de Lévis,
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients > 12 years
- IBD Outpatients from a tertiary gastroenterological health care center willing to participate.
- Patients diagnosed with Ulcerative Colitis (UC) or Crohn's disease (CD), according to classical criteria (laboratory testing and exclusion of other possible causes: complete blood count, comprehensive metabolic panel, serological markers e.g. antineutrophil cytoplasmic antibody (ANCA), inflammatory markers in blood and serum: erythrocyte sedimentation rate, C-reactive protein (CRP); fecal occult blood and fecal calprotectin assays; confirmation by endoscopy, histology of a biopsy)
- At least 30% patients should display active disease. This can be defined by a Harvey-Bradshaw index (HBI) > 5 in CD and a clinical Mayo score > 2 in UC
- Remaining patients in clinical remission or only mildly active disease defined by a HBI<7 in CD and a clinical Mayo score < 3 in UC with a stable medical treatment
- In case of a prescribed endoscopy, the observation period starts >3 days after colonoscopy
- Stable care of a treating physician
- Signed informed consent
Exclusion Criteria:
- Other known pathology or predisposition that may interfere with the ability to perform the measurement procedures or that may influence calprotectin levels such as acute diarrhea or chronic use of non-steroidal anti-inflammatory drugs
- Inability to understand the procedures
- Inability to psychologically handle potential test outcomes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IBD patients
IBD patients performing IBDoc calprotectin test and ease-of-use questionnaires
|
Patients are asked to perform a single IBDoc calprotectin home test.
Patients evaluate the ease-of-use of the test, clearness of test results and comprehensiveness of the instructions for use through a specific questionnaire implementing Likert scales.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trueness/ accuracy of patients IBDoc® results
Time Frame: 24 hours
|
Patients' IBDoc results are compared to reference calprotectin values obtained by laboratory methods
|
24 hours
|
Quantifiable feedback from the enrolled patients about the ease-of-use of the test
Time Frame: 24 hours
|
Ease-of-use of the test, clearness of test results and comprehensiveness of the instructions for use is assessed in a questionnaire, with 12 statements, scored on a 1-to-5 Likert scale, with one (1) indicating "I strongly disagree" and five (5) "I strongly agree".
The mean and standard deviation of scores obtained from all participating patients will be evaluated for each statement.
|
24 hours
|
Quantifiable feedback from healthcare providers
Time Frame: 24 hours
|
Quantifiable feedback from the healthcare providers about the ability of the patients to correctly perform the IBDoc® assay.
Assessment will be made through a questionnaire with five (5) statements, scored on a 1-to-5 Likert scale, with one (1) indicating "I strongly disagree" and five (5) "I strongly agree".
The mean and standard deviation of scores obtained from all participating healthcare providers will be evaluated for each statement.
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Greg Rosenfeld, MD, GIRI (GI Research Institute), Vancouver, Canada
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBDoc_UserPerfomance006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Inflammatory Bowel Diseases
-
Centre Hospitalier Universitaire, AmiensFunding from DGOS (PHRC IR 2013 and PRME)CompletedPediatric Inflammatory Bowel DiseaseFrance
-
University of British ColumbiaCompletedInflammatory Bowel Disease 11Canada
-
University of ChicagoTerminatedInflammatory Bowel Disease (IBD)United States
-
University of Wisconsin, MadisonTerminatedInflammatory Bowel Disease (IBD)United States
-
Cedars-Sinai Medical CenterUnknownPediatric Inflammatory Bowel Disease
-
Assiut UniversityNot yet recruitingIBD-Inflammatory Bowel Disease
-
University of Wisconsin, MadisonCompletedInflammatory Bowel Disease (IBD)United States
-
Icahn School of Medicine at Mount SinaiNorthwestern University; The Cleveland Clinic; University of California, Davis; RxHealt...RecruitingInflammatory Bowel Disease (IBD)United States
-
Nemours Children's ClinicNASPGHAN FoundationCompletedInflammatory Bowel Disease (IBD)United States
-
Hull University Teaching Hospitals NHS TrustWellcome/EPSRC Centre for Interventional and Surgical Sciences, University...RecruitingInflammatory Bowel Disease 1United Kingdom
Clinical Trials on IBDoc calprotectin test
-
King's College Hospital NHS TrustCompletedInflammatory Bowel Diseases | Crohn's Disease | Ulcerative Colitis
-
Universitaire Ziekenhuizen KU LeuvenBelgian Inflammatory Bowel Disease Research and Development (BIRD) VZWUnknownCrohn Disease | Colitis, UlcerativeBelgium
-
Technical University of MunichRecruitingProsthetic Joint Infection | Arthroplasty Complications | Prosthetic InfectionGermany
-
The Cleveland ClinicCompletedProsthetic Joint InfectionUnited States
-
Mahidol UniversityCompletedColorectal Cancer | Colitis | Colorectal AdenomaThailand
-
Ferring PharmaceuticalsCompletedMild-to-moderate Ulcerative ColitisPoland, Hungary, Italy, Czechia, Netherlands, Slovakia
-
Sisli Hamidiye Etfal Training and Research HospitalCompletedNAFLD | Obesity, ChildhoodTurkey
-
Kyungpook National University HospitalCompletedUlcerative ColitisKorea, Republic of
-
Fondazione Policlinico Universitario Agostino Gemelli...Completed