Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-31 @ 7:51 PM
Study NCT ID:
NCT02491593
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2015-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009780', 'term': 'Occult Blood'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-05', 'studyFirstSubmitDate': '2015-06-30', 'studyFirstSubmitQcDate': '2015-07-02', 'lastUpdatePostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with high fecal blood output in relation to colorectal cancer', 'timeFrame': 'Up to 36 months', 'description': 'Accuracy of diagnosis in colorectal cancer'}], 'secondaryOutcomes': [{'measure': 'Number of patients with low fecal blood output in relation to colorectal polyps', 'timeFrame': 'Up to 36 months', 'description': 'Accuracy of diagnosis of colorectal polyps'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fecal occult blood'], 'conditions': ['Colorectal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '31906738', 'type': 'DERIVED', 'citation': 'Tsapournas G, Hellstrom PM, Cao Y, Olsson LI. Diagnostic accuracy of a quantitative faecal immunochemical test vs. symptoms suspected for colorectal cancer in patients referred for colonoscopy. Scand J Gastroenterol. 2020 Feb;55(2):184-192. doi: 10.1080/00365521.2019.1708965. Epub 2020 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the outcome of three (3) quantitative immunochemical faecal occult blood test in symptomatic patients.', 'detailedDescription': 'Consecutive patients referred from primary care for colonoscopy due to symptoms are eligible. Patients will receive written information of the study together with the time for colonoscopy. A specific research nurse will call them and for those accepting participation, history and current medication will be collected. Kits will be sent to patients and they will provide three faecal samples before examination. These will be analysed at one certified laboratory.\n\nHemoglobin concentration will be notified in the range of 50 - \\< 1000 ng/mL, or as a negative outcome.\n\nMacroscopic findings at the colonoscopy will be collected, as well as the outcome of the pathological report.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred from primary care for investigation of symptoms potentially caused by colorectal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms associated with colorectal cancer (anemia, change of bowel habits, diarrhoea, constipation, haematochezia, weight loss, anorexia)\n\nExclusion Criteria:\n\n* Screening investigations\n* High-risk patients'}, 'identificationModule': {'nctId': 'NCT02491593', 'acronym': 'FIKA', 'briefTitle': 'Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients', 'orgStudyIdInfo': {'id': 'QFecalBlood 2013/2:7'}}, 'armsInterventionsModule': {'interventions': [{'name': 'fecal occult blood test', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '631 88', 'city': 'Eskilstuna', 'country': 'Sweden', 'facility': 'Unit of Endoscopy', 'geoPoint': {'lat': 59.36661, 'lon': 16.5077}}], 'overallOfficials': [{'name': 'Louise Olsson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Clinical research, Eskilstuna, Uppsala universitet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}