Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT04734093
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2021-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sonographic Signs of Gouty Arthritis in a Cohort of Egyptian Patients: a Cross Sectional Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-02', 'studyFirstSubmitDate': '2021-01-28', 'studyFirstSubmitQcDate': '2021-01-28', 'lastUpdatePostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sonographic signs of gouty arthritis in the knee or 1st MTP joint', 'timeFrame': 'at baseline', 'description': 'Erosions, effusion, echogenic foci, and tophus using OMERACT definitions of sonographic signs of gouty arthritis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sonographic Signs of Gouty Arthritis in Diagnosed and Suspected Patients']}, 'descriptionModule': {'briefSummary': "The study is a cross sectional observational multicenter study. It is established in collaboration with the Egyptian college of rheumatology study group (ECRsg). It is conditioned that all the study participants had either mono- or oligo-arthritis with effusion of the knee or the first metatarsophalangeal (MTP) joint in patients with a known history of gout or at high risk. Patients with any known chronic arthritis, comprising rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus, scleroderma, neuropathic arthritis, seronegative spondyloarthropathy, will be excluded from the study. None of the participants had a history of intra-articular injection or aspiration in the scanned joints for 3 months prior to the inclusion in the study. The sonographers will be blinded for clinical data and the EULAR scanning protocol for the knee and 1st MTP will be considered \\[2\\]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. All the sonographers in the study had an experience between 5 and 10 years in the field of musculoskeletal ultrasound."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be collected from several university clinics all over Egypt. All are aged 40 or more with a history of definite gouty arthritis or at high risk and they have active arthritis of at least one joint.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* mono- or oligo-arthritis with effusion of the knee or the first metatarsophalangeal\n* patients with a known history of gout or at high risk\n\nExclusion Criteria:\n\n* Patients with any known chronic arthritis, comprising rheumatoid arthritis, Sjoegren's syndrome, systemic lupus erythematosus, scleroderma, neuropathic arthritis, seronegative spondyloarthropathy\n* History of intra-articular injection in the last 3 months."}, 'identificationModule': {'nctId': 'NCT04734093', 'briefTitle': 'Sonographic Signs of Gouty Arthritis in a Cohort of Egyptian Patients: a Cross Sectional Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Sonographic Signs of Gouty Arthritis in a Cohort of Egyptian Patients: a Cross Sectional Multicenter Study', 'orgStudyIdInfo': {'id': '21130'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sohag university recruited patients', 'interventionNames': ['Diagnostic Test: Evaluation of sonographic signs of gouty arthritis']}, {'label': 'Minia university recruited patients', 'interventionNames': ['Diagnostic Test: Evaluation of sonographic signs of gouty arthritis']}, {'label': 'Assuit university recruited patients', 'interventionNames': ['Diagnostic Test: Evaluation of sonographic signs of gouty arthritis']}, {'label': 'Kasr Elini recruited patients', 'interventionNames': ['Diagnostic Test: Evaluation of sonographic signs of gouty arthritis']}, {'label': 'Tanta university recruited patients', 'interventionNames': ['Diagnostic Test: Evaluation of sonographic signs of gouty arthritis']}, {'label': 'Monofia university recruited patients', 'interventionNames': ['Diagnostic Test: Evaluation of sonographic signs of gouty arthritis']}, {'label': 'Aswan university recruited patients', 'interventionNames': ['Diagnostic Test: Evaluation of sonographic signs of gouty arthritis']}, {'label': 'Ain shams university recruited patients', 'interventionNames': ['Diagnostic Test: Evaluation of sonographic signs of gouty arthritis']}], 'interventions': [{'name': 'Evaluation of sonographic signs of gouty arthritis', 'type': 'DIAGNOSTIC_TEST', 'description': 'the EULAR scanning protocol for the knee and 1st MTP will be considered \\[2\\]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. Examination of erosions, tophus, double contour, effusion, and echogenic foci will be recorded.', 'armGroupLabels': ['Ain shams university recruited patients', 'Assuit university recruited patients', 'Aswan university recruited patients', 'Kasr Elini recruited patients', 'Minia university recruited patients', 'Monofia university recruited patients', 'Sohag university recruited patients', 'Tanta university recruited patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82749', 'city': 'Sohag', 'state': 'Sohag Governorate', 'country': 'Egypt', 'facility': 'Ahmed Elsaman', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Ahmed Mahrous', 'investigatorAffiliation': 'Sohag University'}}}}