Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-03-01 @ 10:50 PM
Study NCT ID:
NCT02351635
Status:
COMPLETED
Last Update Posted:
2019-01-18
First Post:
2015-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BÜHLMANN fCAL™ ELISA - Aid in Differentiation of IBD From IBS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool samples collected before start of specific medication'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 478}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-17', 'studyFirstSubmitDate': '2015-01-27', 'studyFirstSubmitQcDate': '2015-01-29', 'lastUpdatePostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'IVD Device performance', 'timeFrame': '2 months', 'description': 'The inter-laboratory precision of the device will be investigated across the study laboratories involved.'}], 'primaryOutcomes': [{'measure': 'Clinical value of in vitro diagnostic (IVD) device', 'timeFrame': 'End of Study', 'description': 'Sensitivity, specificity; Positive predictive value (PPV), negative predictive value (NPV) and likelihood ratios (positive and negative)'}], 'secondaryOutcomes': [{'measure': 'normal Calprotectin values', 'timeFrame': 'End of Study', 'description': 'Calprotectin values from normal healthy donors will be calculated'}, {'measure': 'Clinical value of IVD device in pediatric population', 'timeFrame': 'End of Study', 'description': 'Results of the pediatric population will be used as preliminary and exploratory evidence that calprotectin test can be used in this population'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Calprotectin', 'Diagnosis'], 'conditions': ['Inflammatory Bowel Disease', 'Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '22233279', 'type': 'BACKGROUND', 'citation': 'Manz M, Burri E, Rothen C, Tchanguizi N, Niederberger C, Rossi L, Beglinger C, Lehmann FS. Value of fecal calprotectin in the evaluation of patients with abdominal discomfort: an observational study. BMC Gastroenterol. 2012 Jan 10;12:5. doi: 10.1186/1471-230X-12-5.'}, {'pmid': '23449495', 'type': 'BACKGROUND', 'citation': 'Occhipinti K, Smith JW. Irritable bowel syndrome: a review and update. Clin Colon Rectal Surg. 2012 Mar;25(1):46-52. doi: 10.1055/s-0032-1301759.'}, {'pmid': '22926499', 'type': 'BACKGROUND', 'citation': "Kappelman MD, Moore KR, Allen JK, Cook SF. Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured US population. Dig Dis Sci. 2013 Feb;58(2):519-25. doi: 10.1007/s10620-012-2371-5. Epub 2012 Aug 29."}, {'pmid': '22481443', 'type': 'BACKGROUND', 'citation': 'Burri E, Beglinger C. Faecal calprotectin -- a useful tool in the management of inflammatory bowel disease. Swiss Med Wkly. 2012 Apr 5;142:w13557. doi: 10.4414/smw.2012.13557. eCollection 2012.'}, {'pmid': '20634346', 'type': 'BACKGROUND', 'citation': 'van Rheenen PF, Van de Vijver E, Fidler V. Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic meta-analysis. BMJ. 2010 Jul 15;341:c3369. doi: 10.1136/bmj.c3369.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to confirm the sensitivity and specificity of the BÜHLMANN fCAL™ ELISA as an aid in diagnosis to differentiate between Inflammatory Bowel Disease (IBD; Crohn's Disease (CD), Ulcerative Colitis (UC), or indeterminate colitis) and Irritable Bowel Syndrome (IBS).\n\nTo estimate the predictive value of a positive test (positive predictive value (PPV)) and the predictive value of a negative test (Negative Predictive Value (NPV)) using the proposed test outcomes for BÜHLMANN Calprotectin Test results when used in patients referred for diagnostic evaluation with signs and symptoms suggestive of either IBS or IBD.\n\nTo confirm the inter-laboratory consistency of test results for the BÜHLMANN fCAL™ ELISA.\n\nTo provide exploratory observations of test results in patients between the age of 2 and 21 years.\n\nTo provide a sample set from normal subjects with no symptoms or signs of gastrointestinal disease for use in Expected Value Testing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '100 adult subjects with Inflammatory Bowel Disease or Irritable Bowel Syndrome each have provided a stool sample. In addition, 50 pediatric subjects, age 2 years to 21 years, 25 subjects in each diagnostic group (IBD, IBS) will be enrolled. Recruitment of 120 normal subjects who will provide samples.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults or pediatric patients evaluated by a gastroenterological service for investigation of possible inflammatory intestinal disease or IBS. Patients are referred for sub-specialty evaluation of symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia.\n\n * IBD: Eligible subjects will be analyzed as patients with IBD after a confirmed diagnosis of Inflammatory Bowel Disease (CD, UC, or Indeterminate Colitis), based on endoscopy and confirmed by histology of biopsies taken during endoscopy.\n * IBS: Eligible candidate subjects can also include patients who are self-referred with the relevant constellation of complaints. Eligible subjects will be enrolled after having a diagnosis of IBS based on the Rome III criteria confirmed by negative endoscopy including the colon and terminal ileum.\n * other GI Disorders: Eligible subjects will be enrolled after having a diagnosis of a gastrointestinal disorder other than IBD or IBS, confirmed by endoscopy results and other appropriate diagnostic studies.\n * Healthy Controls: Adults (≥22) with no abdominal complaints and no history of IBS, IBD or other chronic intestinal disorder, confirmed by medical history and physical examination at enrolment.\n2. Individuals of either gender, ≥22 years of age (adult samples) or 2 to -21 years of age (pediatric samples).\n3. IBD patients whose diagnostic endoscopy occurred within the previous month.\n4. Individuals able to understand the study and the tasks required, and who sign the Informed Consent Form (adult subjects; ICF) or whose parent/guardian provides consent (ICF) and, if age 7-to-18 years of age, who provide assent (pediatric subjects).\n\nExclusion Criteria:\n\n1. Individuals unable or unwilling to provide a stool specimen.\n2. Individuals with known intestinal cancer, intestinal infection, upper gastrointestinal disease\n3. Individuals receiving chemotherapy or systemic immunosuppressive drugs.\n4. Individuals who have taken, within the previous 2 weeks, protein pump inhibitors or H2-receptor antagonists.\n5. Individuals with previously diagnosed Inflammatory Bowel Disease managed with immunomodulators, 5-ASA (5-aminosalicylic acid) or biologic therapies or who have undergone a surgical resection or diversion procedure.\n6. Individuals who have taken NSAIDs (nonsteroidal anti-inflammatory drugs), including aspirin, on 7 or more days during the 2 weeks before providing the sample.'}, 'identificationModule': {'nctId': 'NCT02351635', 'briefTitle': 'BÜHLMANN fCAL™ ELISA - Aid in Differentiation of IBD From IBS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bühlmann Laboratories AG'}, 'officialTitle': 'Clinical Study of the BÜHLMANN fCAL™ ELISA as an Aid in the Differentiation of Inflammatory Bowel Disease From Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': 'ALP Cal01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IBD', 'description': 'Adult subjects with inflammatory bowel disease, confirmed by endoscopy and histologic support. Fecal calprotectin Level.', 'interventionNames': ['Other: fecal calprotectin level']}, {'label': 'IBS', 'description': 'Adult subjects with Irritable Bowel Syndrome meeting the Rome III criteria. Fecal calprotectin Level.', 'interventionNames': ['Other: fecal calprotectin level']}, {'label': 'other GI disorders', 'description': 'Adult subjects with gastrointestinal disorders other than IBD or IBS. Fecal calprotectin Level.', 'interventionNames': ['Other: fecal calprotectin level']}, {'label': 'pediatric', 'description': 'Pediatric patients (2-21 y) diagnosed with IBD, IBS, or other gastrointestinal disorders. Fecal calprotectin Level.', 'interventionNames': ['Other: fecal calprotectin level']}, {'label': 'healthy controls', 'description': 'Normal adult subjects with no abdominal complaints. Fecal calprotectin Level.', 'interventionNames': ['Other: fecal calprotectin level']}], 'interventions': [{'name': 'fecal calprotectin level', 'type': 'OTHER', 'description': 'Stool sample collected by the subject, sent study laboratories where fecal calprotectin levels are quantified.', 'armGroupLabels': ['IBD', 'IBS', 'healthy controls', 'other GI disorders', 'pediatric']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Center for Clinical & Translational Research & Education', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Gastro Health', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '31201', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Gastroenterology Assocaites of Central Georgia', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle Foundation, Center for Digestive and Liver Disease', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Great Lakes Gastroenterology Research, LLC.', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '23320', 'city': 'Chesapeake', 'state': 'Virginia', 'country': 'United States', 'facility': 'Gastroenterology Associates of Tidewater', 'geoPoint': {'lat': 36.81904, 'lon': -76.27494}}], 'overallOfficials': [{'name': 'Allison Gorman', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ICON Clincal Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bühlmann Laboratories AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ICON Clinical Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}