Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-26 @ 12:22 AM
Study NCT ID:
NCT04209894
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2019-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Subclinical Enthesitis by Ultrasonography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-22', 'studyFirstSubmitDate': '2019-12-14', 'studyFirstSubmitQcDate': '2019-12-23', 'lastUpdatePostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of Subclinical Enthesitis by Ultrasonography in Psoriasis Patients with Psoriasis and Controls: by Ultrasonography; Incidence of Psoriatic Arthritis During Within One 1 Year', 'timeFrame': '1 year.', 'description': 'Incidence of subclinical enthesitis,To investigate the incidence of subclinical enthesitis in patients with psoriasis'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Risk factors of subclinical enthesitis', 'timeFrame': '1 year', 'description': 'To find out predictor factors of subclinical enthesitis in patients with psoriasis. To assess increase in enthesis area and PsA incidence, and show a possible relationship with baseline findings in a prospective 1-year follow-up of patients with PsO.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['subclinical enthesitis', 'psoriasis', 'ultrasound', 'psoriatic arthritis'], 'conditions': ['Enthesitis']}, 'descriptionModule': {'briefSummary': 'Detection of subclinical enthesitis by ultrasonography', 'detailedDescription': 'A total of 30 patients with psoriasis and 30 age-matched healthy controls, all without musculoskeletal diseases, will be recruited. They will undergo dermatological assessment and a blinded ultrasound (US) evaluation. Clinical assessment included demographics, severity of psoriasis and musculoskeletal clinical examination. Evaluation consisted of the detection of grey scale (GS) enthesitis and Power Doppler signal in enthesis areas. The Madrid Sonography Enthesitis Index (MASEI) scoring system was used to quantify the extent of sonographic entheseal abnormalities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Both patients with psoriasis and healthy controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age≥18years\n* Patients with psoriasis without musculoskeletal symptoms\n* Healthy controls\n* No joint involvement and no clinical symptoms and signs of enthesitis and synovitis\n\nExclusion Criteria:\n\n* Have history of gout or arthritis or peripheral neurological disease of lower extremity.\n* Have history of trauma and intensive sport activity in last 2 weeks.\n* Have received any systemic therapy (i.e. DMARD, NSAIDs, corticosteroids, immunosuppressants, retinoids or biological agents) in 3 months\n* Pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT04209894', 'briefTitle': 'Detection of Subclinical Enthesitis by Ultrasonography', 'organization': {'class': 'OTHER', 'fullName': 'Fatih Sultan Mehmet Training and Research Hospital'}, 'officialTitle': 'Detection of Subclinical Enthesitis by Ultrasonography in Psoriasis Patients With Psoriasis and Controls: by Ultrasonography; Incidence of Psoriatic Arthritis During Within One 1 Year', 'orgStudyIdInfo': {'id': 'karamanlioglu.duygu'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Psoriasis', 'description': 'They will undergo dermatological assessment and a blinded ultrasound (US) evaluation.', 'interventionNames': ['Diagnostic Test: Ultrasound']}, {'label': 'Control', 'description': 'They will also undergo dermatological assessment and a blinded ultrasound (US) evaluation.', 'interventionNames': ['Diagnostic Test: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluation consisted of the detection of grey scale (GS) enthesitis and Power Doppler signal in enthesis areas of participants. The Madrid Sonography Enthesitis Index (MASEI) scoring system was used to quantify the extent of sonographic entheseal abnormalities', 'armGroupLabels': ['Control', 'Psoriasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34758', 'city': 'Istanbul', 'state': 'Atasehir', 'country': 'Turkey (Türkiye)', 'facility': 'Fatih Sultan Mehmet Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Duygu Silte Karamanlioglu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fatih Sultan Mehmet Training and Research Hospital'}, {'name': 'Feyza Unlu Ozkan, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Fatih Sultan Mehmet Training and Research Hospital'}, {'name': 'Eylem Ceren Arikan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fatih Sultan Mehmet Training and Research Hospital'}, {'name': 'Betül Zehra Pirdal, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Istanbul Sultangazi District Health Directorate'}, {'name': 'Gulcan Ozturk, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fatih Sultan Mehmet Training and Research Hospital'}, {'name': 'Ilknur Aktas, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fatih Sultan Mehmet Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatih Sultan Mehmet Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Duygu Karamanlıoğlu', 'investigatorAffiliation': 'Fatih Sultan Mehmet Training and Research Hospital'}}}}