[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542120":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":19,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":19,"enrollmentInfo":55,"targetDuration":19,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":28,"whyStopped":19,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"University of Pisa","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sjogren's syndrome","EXPERIMENTAL","patients with Sjogren's syndrome diagnosed according to the ACR\u002FEULAR criteria",[13],"Other: Ultra-High Frequency Ultrasound scan of minor salivary glands",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Ultra-High Frequency Ultrasound scan of minor salivary glands","Patients will undergo ultra-high frequency ultrasonography (70 MHz) of minor salivary glands, and the scans will be assessed using the OMERACT scoring system. Score 0 will be assigned in the presence of normal glandular tissue, Score 1 will correspond to mild glandular alteration, fine echogenicity or diffuse hypo-echogenicity, Score 2 will be assigned to moderate glandular alteration and focal hypoechoic areas with partial conservation of normal parenchyma, while in Score 3 diffuse presence of hypoechoic areas in the absence of normal glandular parenchyma with glandular fibrosis will be observed.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Rossana Izzetti","CONTACT","+39050993037","rossana.izzetti@unipi.it",[27],{"facility":5,"status":28,"city":29,"state":19,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"RECRUITING","Pisa","56126","Italy","IT",{"type":34,"coordinates":35},"Point",[36,37],10.4036,43.70853,{"lat":37,"lon":36},[40,41],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"name":22,"role":42,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"type":42,"investigatorFullName":22,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Researcher at the Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine of the University of Pisa, Principal Investigator","100542120","ultra-high-frequency-ultrasonography-in-sjgrens-syndrome-100542120",false,"NCT06338735","Ultra-High Frequency Ultrasonography in Sjögren's Syndrome","Ultra-High Frequency Ultrasonography (UHFUS) Evaluation of Salivary Glands in Patients With Suspected Sjögren's Syndrome","UltraSjögren","Inclusion Criteria:\n\n* adults ≥ 18 years of age\n* clinical suspect of Sjogren\\'s syndrome\n* acceptance to undergo complete Sjogren\\'s Syndrome diagnostic work-up\n* acceptance to be included in the study.\n\nExclusion Criteria:\n\n* pregnancy or breastfeeding\n* any acute or chronic condition that would limit the ability of the patient to participate in the study\n* refusal to give informed consent","ALL","18 Years",{"count":56,"type":57},800,"ESTIMATED","INTERVENTIONAL",[60],"NA","Patients diagnosed with a diagnosis of Sjogren's syndrome performed according to the ACR\u002FEULAR criteria will be included in the study. Sjogren's syndrome diagnosis will be performed following a complete diagnostic work-up involving rheumatologic assessment, glandular functional tests, and blood testing for anti-Ro(SSA) antibodies. Conventional ultrasonography of major salivary glands and ultra-high frequency ultrasonography (70 MHz) of minor salivary glands will be performed, and the scans assessed using the Outcome Measures in Rheumatology (OMERACT) scoring system (Score 0 normal glandular tissue, Score 1 mild glandular alteration, fine echogenicity or diffuse hypo-echogenicity, Score 2 moderate glandular alteration and focal hypoechoic areas with partial conservation of normal parenchyma, Score 3 diffuse presence of hypoechoic areas in the absence of normal glandular parenchyma with glandular fibrosis. Focus Score will be assessed following biopsy of minor salivary glands.",[63],"Sjogren's Syndrome",[65,66,9,67],"ultra-high frequency ultrasonography","diagnostic imaging","salivary glands","2024-06-24",{"date":70,"type":71},"2024-06-26","ACTUAL",{"date":73,"type":71},"2016-01-11",{"date":75,"type":57},"2030-12",{"name":5,"class":6},1]