[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502228":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":39,"studyPopulation":40,"armGroups":41,"interventions":35,"overallOfficials":45,"centralContacts":50,"locations":60,"responsibleParty":298,"collaborators":35,"id":300,"slug":35,"hasResults":301,"nctId":302,"briefTitle":303,"officialTitle":303,"acronym":35,"eligibilityCriteria":304,"healthyVolunteers":301,"sex":305,"minAge":306,"maxAge":35,"enrollmentInfo":307,"targetDuration":35,"studyType":310,"phases":35,"briefSummary":311,"conditions":312,"keywords":314,"overallStatus":82,"whyStopped":35,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":325},{"fullName":5,"class":6},"Fondazione Italiana Linfomi - ETS","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Overall survival (OS)","Overall survival, the percentage of patients alive of the cohort (patients with cardiac lymphoma diagnosed from 01\u002F01\u002F2000 to 31\u002F12\u002F2020).","The endpoint will be evaluated within 2 months from the end of data collection. The end of data collection is scheduled within the Q4 (fourth quarter) of 2023.",[14,17,20,23,26,29,32],{"measure":15,"description":16,"timeFrame":12},"Complete remission (CR)","The Complete Remission is defined as the lack of detectable evidence of tumor in the cohort of patients (patients with cardiac lymphoma diagnosed from 01\u002F01\u002F2000 to 31\u002F12\u002F2020).",{"measure":18,"description":19,"timeFrame":12},"Overall Response Rate (ORR)","The Overall Response Rate is defined as the proportion of patients who have a partial or complete response to therapy (patients with cardiac lymphoma diagnosed from 01\u002F01\u002F2000 to 31\u002F12\u002F2020).",{"measure":21,"description":22,"timeFrame":12},"Progression-Fee Survival (PFS)","The Progression-Free Survival is the length of time during and after the treatment that patients live with the disease, but it does not get worse (patients with cardiac lymphoma diagnosed from 01\u002F01\u002F2000 to 31\u002F12\u002F2020).",{"measure":24,"description":25,"timeFrame":12},"Frequencies of the type of chemo(immuno)therapy and of the number of cycles received as first and second line.","The numbers of treatment types and numbers of cycles of therapy received by the cohort of patients (patients with cardiac lymphoma diagnosed from 01\u002F01\u002F2000 to 31\u002F12\u002F2020).",{"measure":27,"description":28,"timeFrame":12},"Frequencies of the type of Central Nervous System (CNS) prophylaxis","The numbers of treatment prophylaxis types for Central Nervous System administered to the cohort of patients (patients with cardiac lymphoma diagnosed from 01\u002F01\u002F2000 to 31\u002F12\u002F2020).",{"measure":30,"description":31,"timeFrame":12},"Cumulative incidence rate of Central Nervous System (CNS) relapse detected during treatment or follow-up.","The proportion of patients with disease relapse on Central Nervous System (CNS)",{"measure":33,"description":34,"timeFrame":12},"Characteristics of patients","Analysis of the following characteristics: Age, gender, disease localization (atria, ventricles, cardiac arteries and veins, pericardium), HIV positivity, type of symptoms at diagnosis.",null,{"allocation":35,"interventionModel":35,"interventionModelDescription":35,"primaryPurpose":35,"observationalModel":37,"timePerspective":38,"maskingInfo":35},"COHORT","RETROSPECTIVE","Primary cardiac lymphoma (PCL), an extranodal lymphoma involving only the heart (with possible involvement of the pericardium) is a rare entity, accounting for 2% of primary cardiac tumors and 0.5% of extranodal lymphomas. It is more frequent in males; clinical presentation is predominated by cardiac symptoms. The most common histology is Diffuse Large B Cell Lymphoma (DLBCL). Being DLBCL the most frequent histology, patients are usually treated with R-CHOP (rituximab - cyclophosphamide, doxorubicin, vincristine and prednisone) or R-CHOP-like chemoimmunotherapy regimens, with an historically poor outcome, although in the last years survival rates significantly increased. Due to the rarity of this condition, isolated case reports and a few reviews have been published so far, that in most cases included a population collected in a wide period of time, heterogeneously managed both in terms of treatments received and follow-up, and who often did not strictly respect the criteria of PCL. Indeed, while some aspects of PCL are well-known, especially the ones concerning its clinical presentation, a few topics deserve more in-depth analysis. The rationale of this study is to provide an overview on PCL in Italy, trying to shed light on unknown aspects of the disease and on unanswered questions about its management that could be helpful in clinical practice.","Patient affected by primary cardiac lymphoma from 1st January 2000 to 31st December 2020.",[42],{"label":43,"type":35,"description":44,"interventionNames":35},"Patients enrolled","Patients with a diagnosis primary cardiac lymphoma. The study includes patients with PCL diagnosed from 01\u002F01\u002F2000 to 31\u002F12\u002F2020.",[46],{"name":47,"affiliation":48,"role":49},"Elisa Lucchini, MD","Trieste - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia","PRINCIPAL_INVESTIGATOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":35,"email":55},"Giorgio Priolo","CONTACT","0131.033175","gpriolo@filinf.it",{"name":57,"role":53,"phone":58,"phoneExt":35,"email":59},"Samantha Deianira Dattoli","0599769914","sdattoli@filinf.it",[61,80,96,110,125,139,153,167,181,192,203,217,231,245,256,270,284],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Presidio ospedaliero \"A. TORTORA\" - U.O. Onco-ematologia","NOT_YET_RECRUITING","Pagani","Salerno","84016","Italy","IT",{"type":70,"coordinates":71},"Point",[72,73],14.61448,40.74199,{"lat":73,"lon":72},[76,79],{"name":77,"role":53,"phone":35,"phoneExt":35,"email":78},"Catello Califano, MD","c.califano@aslsalerno.it",{"name":77,"role":49,"phone":35,"phoneExt":35,"email":35},{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":67,"countryCode":68,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"AOU di Sassari - Ematologia","RECRUITING","Sassari","SS","07100",{"type":70,"coordinates":87},[88,89],8.55552,40.72586,{"lat":89,"lon":88},[92,95],{"name":93,"role":53,"phone":35,"phoneExt":35,"email":94},"Claudio Fozza, MD","cfozza@uniss.it",{"name":93,"role":49,"phone":35,"phoneExt":35,"email":35},{"facility":97,"status":82,"city":98,"state":99,"zip":100,"country":67,"countryCode":68,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia","Trieste","TS","34121",{"type":70,"coordinates":102},[103,104],13.77678,45.64953,{"lat":104,"lon":103},[107,109],{"name":47,"role":53,"phone":35,"phoneExt":35,"email":108},"elisa.lucchini@asugi.sanita.fvg.it",{"name":47,"role":49,"phone":35,"phoneExt":35,"email":35},{"facility":111,"status":63,"city":112,"state":113,"zip":114,"country":67,"countryCode":68,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Ospedale Dell'angelo - U.O. Ematologia","Mestre","Venezia","30174",{"type":70,"coordinates":116},[117,118],12.24538,45.49167,{"lat":118,"lon":117},[121,124],{"name":122,"role":53,"phone":35,"phoneExt":35,"email":123},"Cristina Skert, MD","cristina.skert@aulss3.veneto.it",{"name":122,"role":49,"phone":35,"phoneExt":35,"email":35},{"facility":126,"status":82,"city":127,"state":35,"zip":128,"country":67,"countryCode":68,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Azienda Ospedaliera Papa Giovanni XXIII - Ematologia","Bergamo","24127",{"type":70,"coordinates":130},[131,132],9.66721,45.69601,{"lat":132,"lon":131},[135,138],{"name":136,"role":53,"phone":35,"phoneExt":35,"email":137},"Giuseppe Gritti, MD","g.gritti@asst-pg23.it",{"name":136,"role":49,"phone":35,"phoneExt":35,"email":35},{"facility":140,"status":82,"city":141,"state":35,"zip":142,"country":67,"countryCode":68,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"ASST Spedali Civili di Brescia - Ematologia","Brescia","25123",{"type":70,"coordinates":144},[145,146],10.21472,45.53558,{"lat":146,"lon":145},[149,152],{"name":150,"role":53,"phone":35,"phoneExt":35,"email":151},"Rosa Daffini, MD","rosadaffini@yahoo.it",{"name":150,"role":49,"phone":35,"phoneExt":35,"email":35},{"facility":154,"status":82,"city":155,"state":35,"zip":156,"country":67,"countryCode":68,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna - Ematologia e fisiopatologia della coagulazione","Ferrara","44124",{"type":70,"coordinates":158},[159,160],11.62057,44.83804,{"lat":160,"lon":159},[163,166],{"name":164,"role":53,"phone":35,"phoneExt":35,"email":165},"Mariarosaria Sessa, MD","sessamariarosaria@gmail.com",{"name":164,"role":49,"phone":35,"phoneExt":35,"email":35},{"facility":168,"status":82,"city":169,"state":35,"zip":170,"country":67,"countryCode":68,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia","Milan","20132",{"type":70,"coordinates":172},[173,174],12.59836,42.78235,{"lat":174,"lon":173},[177,180],{"name":178,"role":53,"phone":35,"phoneExt":35,"email":179},"Andrés JM Ferreri, MD","andres.ferreri@hsr.it",{"name":178,"role":49,"phone":35,"phoneExt":35,"email":35},{"facility":182,"status":82,"city":169,"state":35,"zip":183,"country":67,"countryCode":68,"cosmosGeoPoint":184,"geoPoint":186,"contacts":187},"Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia","20133",{"type":70,"coordinates":185},[173,174],{"lat":174,"lon":173},[188,191],{"name":189,"role":53,"phone":35,"phoneExt":35,"email":190},"Anna Guidetti, MD","anna.guidetti@istitutotumori.mi.it",{"name":189,"role":49,"phone":35,"phoneExt":35,"email":35},{"facility":193,"status":82,"city":169,"state":35,"zip":194,"country":67,"countryCode":68,"cosmosGeoPoint":195,"geoPoint":197,"contacts":198},"ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia","20162",{"type":70,"coordinates":196},[173,174],{"lat":174,"lon":173},[199,202],{"name":200,"role":53,"phone":35,"phoneExt":35,"email":201},"Erika Ravelli, MD","erika.ravelli@ospedaleniguarda.it",{"name":200,"role":49,"phone":35,"phoneExt":35,"email":35},{"facility":204,"status":82,"city":205,"state":35,"zip":206,"country":67,"countryCode":68,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Ospedale S. Maria della Misericordia - Ematologia","Perugia","06129",{"type":70,"coordinates":208},[209,210],12.38878,43.1122,{"lat":210,"lon":209},[213,216],{"name":214,"role":53,"phone":35,"phoneExt":35,"email":215},"Leonardo Flenghi, MD","leonardo.flenghi@ospedale.perugia.it",{"name":214,"role":49,"phone":35,"phoneExt":35,"email":35},{"facility":218,"status":63,"city":219,"state":35,"zip":220,"country":67,"countryCode":68,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"AOU Pisana - U.O. Ematologia","Pisa","56126",{"type":70,"coordinates":222},[223,224],10.4036,43.70853,{"lat":224,"lon":223},[227,230],{"name":228,"role":53,"phone":35,"phoneExt":35,"email":229},"Sara Galimberti, MD","sara.galimberti@med.unipi.it",{"name":228,"role":49,"phone":35,"phoneExt":35,"email":35},{"facility":232,"status":63,"city":233,"state":35,"zip":234,"country":67,"countryCode":68,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"Roma - Universitа Cattolica S. Cuore - Ematologia","Roma","00168",{"type":70,"coordinates":236},[237,238],11.10642,44.99364,{"lat":238,"lon":237},[241,244],{"name":242,"role":53,"phone":35,"phoneExt":35,"email":243},"Stefan Hohaus, MD","stefan.hohaus@unicatt.it",{"name":242,"role":49,"phone":35,"phoneExt":35,"email":35},{"facility":246,"status":82,"city":233,"state":35,"zip":247,"country":67,"countryCode":68,"cosmosGeoPoint":248,"geoPoint":250,"contacts":251},"AO Sant'Andrea - Ematologia","00183",{"type":70,"coordinates":249},[237,238],{"lat":238,"lon":237},[252,255],{"name":253,"role":53,"phone":35,"phoneExt":35,"email":254},"Agostino Tafuri, MD","agostino.tafuri@ospedalesantandrea.it",{"name":253,"role":49,"phone":35,"phoneExt":35,"email":35},{"facility":257,"status":63,"city":258,"state":35,"zip":259,"country":67,"countryCode":68,"cosmosGeoPoint":260,"geoPoint":264,"contacts":265},"A.O. S. Maria di Terni - S.C. Oncoematologia","Terni","05100",{"type":70,"coordinates":261},[262,263],12.64329,42.56335,{"lat":263,"lon":262},[266,269],{"name":267,"role":53,"phone":35,"phoneExt":35,"email":268},"Anna Marina Liberati, MD","marina.liberati@unipg.it",{"name":267,"role":49,"phone":35,"phoneExt":35,"email":35},{"facility":271,"status":63,"city":272,"state":35,"zip":273,"country":67,"countryCode":68,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria","Torino","10126",{"type":70,"coordinates":275},[276,277],11.99138,44.88856,{"lat":277,"lon":276},[280,283],{"name":281,"role":53,"phone":35,"phoneExt":35,"email":282},"Federica Cavallo, MD","f.cavallo@unito.it",{"name":281,"role":49,"phone":35,"phoneExt":35,"email":35},{"facility":285,"status":82,"city":286,"state":35,"zip":287,"country":67,"countryCode":68,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"AOU Integrata di Verona - U.O. Ematologia","Verona","37134",{"type":70,"coordinates":289},[290,291],10.9938,45.43854,{"lat":291,"lon":290},[294,297],{"name":295,"role":53,"phone":35,"phoneExt":35,"email":296},"Isacco Ferrarini, MD","isacco.ferrarini@univr.it",{"name":295,"role":49,"phone":35,"phoneExt":35,"email":35},{"type":299,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100502228",false,"NCT05819528","Primary Cardiac Lymphoma: Italian Multicenter Experience","Inclusion Criteria:\n\n* Diagnosis of PCL (any histotype) defined as an extranodal lymphoma involving only the heart with possible involvement of the pericardium.\n* Age ≥18 years.\n* Diagnosis histologically confirmed. Cytofluorimetry analysis of pericardial fluid showing phenotypic features consistent with a primary cardiac lymphoma is permitted if a biopsy sample is not feasible\u002Favailable for diagnosis; monoclonality is not accepted as a surrogate for diagnosis.\n* Date of diagnosis: from 1st January 2000 to 31st December 2020.\n* Only patients treated in first-line with chemoimmunotherapy regimens including an anti-CD20 monoclonal antibody are eligible for the study.\n* Signed written informed consent (in case of unreachable subject please see chapter 11.2)\n\nExclusion Criteria:\n\n* Secondary cardiac involvement from lymphoma; primary mediastinal lymphoma with pericardial infiltration or other lymphomas with involvement of the pericardium\u002Fthe heart by contiguity and primary effusion lymphoma are not included in this study.\n* Patients treated with chemotherapy regimens that did not include an anti-CD20 monoclonal antibody as first-line therapy.\n* Refuse to sign a written informed consent","ALL","18 Years",{"count":308,"type":309},43,"ESTIMATED","OBSERVATIONAL","The rationale of this study is to provide an overview on PCL (Primary Cardiac Lymphoma) in Italy, trying to shed light on unknown aspects of the disease and on unanswered questions about its management that could be helpful in clinical practice.",[313],"Primary Cardiac Lymphoma",[315],"PCL","2025-12-31",{"date":318,"type":319},"2026-01-05","ACTUAL",{"date":321,"type":319},"2024-10-02",{"date":323,"type":309},"2026-06",{"name":5,"class":6},17]