[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573693":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":31,"studyPopulation":32,"armGroups":33,"interventions":13,"overallOfficials":13,"centralContacts":37,"locations":43,"responsibleParty":196,"collaborators":13,"id":198,"slug":13,"hasResults":199,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":199,"sex":204,"minAge":205,"maxAge":206,"enrollmentInfo":207,"targetDuration":13,"studyType":210,"phases":13,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":46,"whyStopped":13,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},{"fullName":5,"class":6},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":14},[9],{"measure":10,"description":11,"timeFrame":12},"Correlation between the primary ovarian leiomyosarcoma treatment and prognosis","Correlation between survival outcomes and treatments (type of surgery ,type of chemotherapy, hormone therapy, radiotherapy).","3 years observation period",null,[15,19,22,25],{"measure":16,"description":17,"timeFrame":18},"Correlation between the mitotic index and Ki67","Number of mitotic figures and levels of Ki67 expression in immunohistochemical staining","through study completion, an average of 1 year",{"measure":20,"description":21,"timeFrame":12},"Correlation between the mitotic index and progression of disease","Correlation between survival outcomes and mitotic index",{"measure":23,"description":24,"timeFrame":12},"Overall Survival","Time from diagnosis to death from any cause, measured in months.",{"measure":26,"description":27,"timeFrame":12},"Progression free survival in the overall population","Time from diagnosis to disease progression or death, whichever occurs first, measured in months.",{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":29,"timePerspective":30,"maskingInfo":13},"COHORT","OTHER","This study adopts a national, multicenter, observational design, incorporating both retrospective and prospective methodologies to collect and analyze primary ovarian leiomyosarcoma (POLMS) cases. The retrospective component will include cases diagnosed since 1980, leveraging institutional archives and clinical case reviews.\n\nData collection will be standardized using an electronic Case Report Form (eCRF) implemented on REDCap. All data will be centralized for uniformity and undergo rigorous validation to ensure consistency across centers. Findings will be reported in aggregated form to preserve patient confidentiality.\n\nThe study will gather extensive data points, including:\n\n* Patient demographics.\n* Clinical presentation and tumor characteristics (symptoms, tumor markers such as CA-125, CEA, and Ki-67).\n* Treatment modalities (surgical details, lymphadenectomy, chemotherapy, radiotherapy, or hormonal therapy).\n* Recurrence patterns and outcomes (disease-free survival, overall survival).\n* Immunohistochemical findings (positivity for desmin, SMA, and vimentin). The statistical analysis primarily involves descriptive and exploratory techniques to identify patterns and correlations within the dataset.","Consent for study participation will be obtained from living patients during follow-up visits. Historical cases with remote diagnoses since 1980 will be accessed through clinical case reviews in the databases of each participating center. For patients lost to follow-up or deceased, a waiver of informed consent has been obtained from the Ethics Committee by applicable regulations.",[34],{"label":35,"type":13,"description":36,"interventionNames":13},"Primary leiomyosarcoma of the ovary (POLMS)","The study population includes patients aged between 18 and 99 years diagnosed with primary ovarian leiomyosarcoma (POLMS) afferent to participating centers. This population encompasses both historical cases diagnosed since 1980 and new cases identified during the study period.",[38],{"name":39,"role":40,"phone":41,"phoneExt":13,"email":42},"Vincenzo Dario Mandato, MD","CONTACT","+39 0522 295467","vincenzodario.mandato@ausl.re.it",[44,63,79,96,111,126,141,156,171,182],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":48,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"AOU Policlinico di Modena","RECRUITING","Modena","Italy","41125","IT",{"type":52,"coordinates":53},"Point",[54,55],10.92539,44.64783,{"lat":55,"lon":54},[58,61],{"name":59,"role":40,"phone":13,"phoneExt":13,"email":60},"Cinzia Baldessari, MD","Baldessari.cinzia@aou.mo.it",{"name":59,"role":62,"phone":13,"phoneExt":13,"email":13},"PRINCIPAL_INVESTIGATOR",{"facility":64,"status":46,"city":65,"state":66,"zip":67,"country":48,"countryCode":50,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Azienda Ospedaliero Universitaria di Parma - S.C. Ostetricia e Ginecologia","Parma","PR","43126",{"type":52,"coordinates":69},[70,71],10.32618,44.79935,{"lat":71,"lon":70},[74,78],{"name":75,"role":40,"phone":76,"phoneExt":13,"email":77},"Roberto Berretta, MD","+390521704068","roberto.berrettamd@gmail.com",{"name":75,"role":62,"phone":13,"phoneExt":13,"email":13},{"facility":80,"status":46,"city":81,"state":82,"zip":83,"country":48,"countryCode":50,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Azienda USL IRCCS di Reggio Emilia","Reggio Emilia","RE","42123",{"type":52,"coordinates":85},[86,87],10.63125,44.69825,{"lat":87,"lon":86},[90,94],{"name":91,"role":40,"phone":92,"phoneExt":13,"email":93},"Jasmine Lonetti, Clinical Research Coordinator","+39 0522295467","jasmine.lonetti@ausl.re.it",{"name":95,"role":62,"phone":13,"phoneExt":13,"email":13},"Vincenzo Mandato",{"facility":97,"status":46,"city":98,"state":13,"zip":99,"country":48,"countryCode":50,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Malzoni - Avellino","Avellino","83100",{"type":52,"coordinates":101},[102,103],14.79103,40.91494,{"lat":103,"lon":102},[106,110],{"name":107,"role":40,"phone":108,"phoneExt":13,"email":109},"Francesca Falcone, MD","+39 0825 25596","francesca.falcone3@icloud.com",{"name":107,"role":62,"phone":13,"phoneExt":13,"email":13},{"facility":112,"status":46,"city":113,"state":13,"zip":114,"country":48,"countryCode":50,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Azienda Ospedaliero Universitaria Policlinico \"G.Rodolico - San Marco\" - Catania","Catania","95123",{"type":52,"coordinates":116},[117,118],15.07041,37.49223,{"lat":118,"lon":117},[121,125],{"name":122,"role":40,"phone":123,"phoneExt":13,"email":124},"Liliana Mereu, MD","+39 095 479 4111","liliana.mereu@unict.it",{"name":122,"role":62,"phone":13,"phoneExt":13,"email":13},{"facility":127,"status":46,"city":128,"state":13,"zip":129,"country":48,"countryCode":50,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"IRCCS Ospedale San Raffaele","Milan","20132",{"type":52,"coordinates":131},[132,133],12.59836,42.78235,{"lat":133,"lon":132},[136,140],{"name":137,"role":40,"phone":138,"phoneExt":13,"email":139},"Raffaella Cioffi, MD PhD","02 2643 4880","raffaella.cioffi@hsr.it",{"name":137,"role":62,"phone":13,"phoneExt":13,"email":13},{"facility":142,"status":46,"city":143,"state":13,"zip":13,"country":48,"countryCode":50,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Fondazione Irccs San Gerardo Dei Tintori","Monza",{"type":52,"coordinates":145},[146,147],9.27246,45.58005,{"lat":147,"lon":146},[150,154],{"name":151,"role":40,"phone":152,"phoneExt":13,"email":153},"Tommaso Grassi, MD","039 2331","tommaso.grassi@irccs-sangerardo.it",{"name":155,"role":62,"phone":13,"phoneExt":13,"email":13},"Tommaso Grassi",{"facility":157,"status":46,"city":158,"state":13,"zip":159,"country":48,"countryCode":50,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"IRCCS Istituto Nazionale Tumori Fondazione Pascale","Naples","80131",{"type":52,"coordinates":161},[162,163],14.26811,40.85216,{"lat":163,"lon":162},[166,170],{"name":167,"role":40,"phone":168,"phoneExt":13,"email":169},"Jole Ventriglia, MD","+39 081 17770468","j.ventriglia@istitutotumori.na.it",{"name":167,"role":62,"phone":13,"phoneExt":13,"email":13},{"facility":172,"status":46,"city":158,"state":13,"zip":13,"country":48,"countryCode":50,"cosmosGeoPoint":173,"geoPoint":175,"contacts":176},"Università degli Studi di Napoli Federico II",{"type":52,"coordinates":174},[162,163],{"lat":163,"lon":162},[177,181],{"name":178,"role":40,"phone":179,"phoneExt":13,"email":180},"Roberto Bianco, MD PhD","081-7462061","roberto.bianco@unina.it",{"name":178,"role":62,"phone":13,"phoneExt":13,"email":13},{"facility":183,"status":46,"city":184,"state":13,"zip":13,"country":48,"countryCode":50,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Ospedale \"Sacro Cuore\"","Verona",{"type":52,"coordinates":186},[187,188],10.9938,45.43854,{"lat":188,"lon":187},[191,195],{"name":192,"role":40,"phone":193,"phoneExt":13,"email":194},"Giovanni Roviglione, MD","0456014581","giovanni.roviglione@sacrocuore.it",{"name":192,"role":62,"phone":13,"phoneExt":13,"email":13},{"type":197,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100573693",false,"NCT06749600","Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma","POLMS","Inclusion Criteria:\n\n* Diagnosis of primary leiomyosarcoma of the ovary;\n* Patients diagnosed with POLMS for whom data relating to diagnosis and treatment are available.\n* Aged between 18 and 99 years\n\nExclusion Criteria:\n\n\\- All patients with other forms of ovarian sarcoma (rhabdomyosarcomas, fibrosarcomas, stromal cell sarcomas) and patients diagnosed with leiomyosarcoma of the uterus will be excluded.","FEMALE","18 Years","99 Years",{"count":208,"type":209},30,"ESTIMATED","OBSERVATIONAL","This observational study aims to gather comprehensive data on primary ovarian leiomyosarcoma (POLMS). This extremely rare malignancy accounts for less than 3% of primary ovarian malignancies and has an incidence of only 1% among ovarian cancers. This national, retrospective and prospective multicenter study will collect and analyze historical cases of POLMS with remote diagnoses accessed through clinical case reviews and newly identified cases. The study aims to expand a previously identified series of 113 cases described in the literature, uncovering patterns in diagnosis, treatment, and outcomes and ultimately establishing evidence-based guidelines for the optimal management of this rare and aggressive cancer.",[213],"Primary Ovarian Leiomyosarcoma",[215,216,217,218,219,220,221,222,223,224],"Primary ovarian leiomyosarcoma","Gynecologic oncology","Neoplasms, Muscle Tissue","Neoplasms, Connective and Soft Tissue","Neoplasms by Histologic Type","Sarcoma","Neoplasms","Histopathology","Prognostic factors","Tumor markers","2026-05-04",{"date":227,"type":228},"2026-05-05","ACTUAL",{"date":230,"type":228},"2024-06-14",{"date":232,"type":209},"2027-12-31",{"name":5,"class":6},10]