[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502022":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":25,"studyPopulation":26,"armGroups":27,"interventions":33,"overallOfficials":43,"centralContacts":48,"locations":57,"responsibleParty":394,"collaborators":21,"id":396,"slug":21,"hasResults":397,"nctId":398,"briefTitle":399,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":397,"sex":402,"minAge":403,"maxAge":21,"enrollmentInfo":404,"targetDuration":21,"studyType":407,"phases":21,"briefSummary":408,"conditions":409,"keywords":411,"overallStatus":60,"whyStopped":21,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":433},{"fullName":5,"class":6},"Fondazione Italiana Linfomi - ETS","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Progression free survival","Time between the treatment start and the first documentation of recurrence, progression or death from any cause","From treatment start up to 43 months",[14,18],{"measure":15,"description":16,"timeFrame":17},"Response rate","Response rate (complete metabolic response\u002Fminimal residual disease (MRD) negativity) at the end of induction.","From treatment start to 7 months (R-Bendamustine) or from treatment start to 5,6 months (R-CHOP)",{"measure":19,"description":19,"timeFrame":20},"Concordance between EZH2 gene mutations\u002Fgains and EZH2-related gene expression signature","Before treatment start",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"COHORT","RETROSPECTIVE","Current standard first-line treatment for advanced follicular lymphoma (FL) is still represented by chemoimmunotherapy combinations, with CHOP\u002FCVP or bendamustine (B) as the main regimens with no standard criteria to prefer one over another.\n\nEZH2 mutations have been associated with longer progression-free survival (PFS) in patients treated with CHOP\u002FCVP regimens, but not with Bendamustine (independently from the type of anti-CD20 therapy received).\n\nThe FIL\\_FOLL12 trial (NCT02063685), a large phase III trial (with a pre-planned biological material sampling) enrolling 807 advanced FL patients treated with front-line R-CHOP or bendamustine-rituximab (BR), appears an ideal platform to validate the predictive value of EZH2 and its applicability to the clinical practice.\n\nThe aim of this study is to provide to clinicians a useful and practical biomarker to guide the choice of the most effective chemotherapy backbone (in addition to anti-CD20 immunotherapy) for first line treatment of patients with advanced FL (e.g. R-CHOP for EZH2 aberrated vs BR for EZH2 wild type patients).\n\nMoreover, to implement an Italian network of laboratories able to provide these translational outputs within a rapid turnaround time.\n\nFinally, taking advantage of the already collected BM and PB samples, several novel biomarkers of FL heterogeneity will be investigated, in particular: EZH2 protein expression in tumor samples, alternative molecular markers for minimal residual disease (MRD), clonal hematopoiesis of indeterminate potential (CHIP), pharmacogenomics and constitutional genomics as well as microbiome profiles.","Patient affected by advanced Follicular Lymphoma treated with immunochemotherapy in the FIL\\_FOLL12 trial",[28],{"label":29,"type":21,"description":26,"interventionNames":30},"Patients enrolled",[31,32],"Diagnostic Test: EZH2 mutations\u002FCNAs by droplet digital PCR (ddPCR)","Diagnostic Test: EZH2-derived gene expression signature by RNA-Seq",[34,39],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":21},"DIAGNOSTIC_TEST","EZH2 mutations\u002FCNAs by droplet digital PCR (ddPCR)","Test of EZH2 mutations\u002FCNAs by droplet digital PCR (ddPCR) in peripheral blood and in unsorted bone marrow aspirate samples at enrolment",[29],{"type":35,"name":40,"description":41,"armGroupLabels":42,"otherNames":21},"EZH2-derived gene expression signature by RNA-Seq","Test of EZH2-derived gene expression signature by RNA-Seq in a subset of diagnostic FFPE samples",[29],[44],{"name":45,"affiliation":46,"role":47},"Simone Ferrero, MD","SC Ematologia U - AOU Città della Salute e della Scienza di Torino","PRINCIPAL_INVESTIGATOR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":21,"email":53},"Uffici Studi FIL","CONTACT","+390131033153","startup@filinf.it",{"name":50,"role":51,"phone":55,"phoneExt":21,"email":56},"+390599769913","gestionestudi@filinf.it",[58,75,88,101,114,128,141,154,167,180,190,203,216,229,242,255,268,281,294,307,320,333,345,355,368,381],{"facility":59,"status":60,"city":61,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia","RECRUITING","Alessandria","Italy","IT",{"type":65,"coordinates":66},"Point",[67,68],8.61007,44.90924,{"lat":68,"lon":67},[71,74],{"name":72,"role":51,"phone":21,"phoneExt":21,"email":73},"Manuela Zanni, MD","manuela.zanni@ospedale.al.it",{"name":72,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":76,"status":60,"city":77,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Nuovo Ospedale degli Infermi, SSD Ematologia","Biella",{"type":65,"coordinates":79},[80,81],8.05796,45.56304,{"lat":81,"lon":80},[84,87],{"name":85,"role":51,"phone":21,"phoneExt":21,"email":86},"Annarita Conconi, MD","annarita.conconi@aslbi.piemonte.it",{"name":85,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":89,"status":60,"city":90,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"ASST Spedali Civili di Brescia - Ematologia","Brescia",{"type":65,"coordinates":92},[93,94],10.21472,45.53558,{"lat":94,"lon":93},[97,100],{"name":98,"role":51,"phone":21,"phoneExt":21,"email":99},"Antonella Anastasia, MD","antonella.anastasia@gmail.com",{"name":98,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":102,"status":60,"city":103,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Azienda Ospedaliera Universitaria Policlinico - S. Marco, UOC di Ematologia","Catania",{"type":65,"coordinates":105},[106,107],15.07041,37.49223,{"lat":107,"lon":106},[110,113],{"name":111,"role":51,"phone":21,"phoneExt":21,"email":112},"Annalisa Chiarenza, MD","annalisa.chiarenza@gmail.com",{"name":111,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":115,"status":116,"city":117,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo","NOT_YET_RECRUITING","Cuneo",{"type":65,"coordinates":119},[120,121],7.54828,44.39071,{"lat":121,"lon":120},[124,127],{"name":125,"role":51,"phone":21,"phoneExt":21,"email":126},"Claudia Castellino, MD","castellino.c@ospedale.cuneo.it",{"name":125,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":129,"status":116,"city":130,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia","Florence",{"type":65,"coordinates":132},[133,134],11.24626,43.77925,{"lat":134,"lon":133},[137,140],{"name":138,"role":51,"phone":21,"phoneExt":21,"email":139},"Benedetta Puccini, MD","puccinib@aou-careggi.toscana.it",{"name":138,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":142,"status":60,"city":143,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia, Ematologia e terapie cellulari","Genova",{"type":65,"coordinates":145},[146,147],11.87211,45.21604,{"lat":147,"lon":146},[150,153],{"name":151,"role":51,"phone":21,"phoneExt":21,"email":152},"Chiara Ghiggi, MD","chiara.ghiggi@hsanmartino.it",{"name":151,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":155,"status":60,"city":156,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"IRCCS Istituto Romagnolo per lo studio dei Tumori \"Dino Amadori\" - IRST S.R.L., Ematologia","Meldola",{"type":65,"coordinates":158},[159,160],12.0626,44.12775,{"lat":160,"lon":159},[163,166],{"name":164,"role":51,"phone":21,"phoneExt":21,"email":165},"Gerardo Musuraca, MD","gerardo.musuraca@irst.emr.it",{"name":164,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":168,"status":60,"city":169,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia","Milan",{"type":65,"coordinates":171},[172,173],12.59836,42.78235,{"lat":173,"lon":172},[176,179],{"name":177,"role":51,"phone":21,"phoneExt":21,"email":178},"Vittorio Ruggero Zilioli, MD","vittorioruggero.zilioli@ospedaleniguarda.it",{"name":177,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":181,"status":60,"city":169,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":182,"geoPoint":184,"contacts":185},"Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia",{"type":65,"coordinates":183},[172,173],{"lat":173,"lon":172},[186,189],{"name":187,"role":51,"phone":21,"phoneExt":21,"email":188},"Paolo Corradini, MD","paolo.corradini@unimi.it",{"name":187,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":191,"status":60,"city":192,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Azienda Ospedaliero-Universitaria Policlinico di Modena, U.O. Oncologia","Modena",{"type":65,"coordinates":194},[195,196],10.92539,44.64783,{"lat":196,"lon":195},[199,202],{"name":200,"role":51,"phone":21,"phoneExt":21,"email":201},"Alessia Bari, MD","alessia.bari@unimore.it",{"name":200,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":204,"status":60,"city":205,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Fondazione IRCCS San Gerardo dei Tintori - Ematologia","Monza",{"type":65,"coordinates":207},[208,209],9.27246,45.58005,{"lat":209,"lon":208},[212,215],{"name":213,"role":51,"phone":21,"phoneExt":21,"email":214},"Silvia Bolis, MD","silviaanna.bolis@irccs-sangerardo.it",{"name":213,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":217,"status":60,"city":218,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"AOU Maggiore della Carità di Novara, SCDU Ematologia","Novara",{"type":65,"coordinates":220},[221,222],8.62118,45.44694,{"lat":222,"lon":221},[225,228],{"name":226,"role":51,"phone":21,"phoneExt":21,"email":227},"Riccardo Moia, MD","riccardo.moia@uniupo.it",{"name":226,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":230,"status":60,"city":231,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Presidio ospedaliero \"A. Tortora\", U.O. Onco-ematologia","Pagani",{"type":65,"coordinates":233},[234,235],14.61448,40.74199,{"lat":235,"lon":234},[238,241],{"name":239,"role":51,"phone":21,"phoneExt":21,"email":240},"Catello Califano, MD","c.califano@aslsalerno.it",{"name":239,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":243,"status":60,"city":244,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"A.O. Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia","Palermo",{"type":65,"coordinates":246},[247,248],13.3636,38.1166,{"lat":248,"lon":247},[251,254],{"name":252,"role":51,"phone":21,"phoneExt":21,"email":253},"Caterina Patti, MD","k.patti@villasofia.it",{"name":252,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":256,"status":116,"city":257,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"IRCCS Policlinico S. Matteo di Pavia, Divisione di Ematologia","Pavia",{"type":65,"coordinates":259},[260,261],9.15917,45.19205,{"lat":261,"lon":260},[264,267],{"name":265,"role":51,"phone":21,"phoneExt":21,"email":266},"Luca Arcaini, MD","luca.arcaini@unipv.it",{"name":265,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":269,"status":60,"city":270,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"Ospedale Guglielmo da Saliceto, U.O. Ematologia","Piacenza",{"type":65,"coordinates":272},[273,274],9.69342,45.05242,{"lat":274,"lon":273},[277,280],{"name":278,"role":51,"phone":21,"phoneExt":21,"email":279},"Annalisa Arcari, MD","a.arcari@ausl.pc.it",{"name":278,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":282,"status":116,"city":283,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":284,"geoPoint":288,"contacts":289},"Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia","Reggio Calabria",{"type":65,"coordinates":285},[286,287],15.66129,38.11047,{"lat":287,"lon":286},[290,293],{"name":291,"role":51,"phone":21,"phoneExt":21,"email":292},"Caterina Stelitano, MD","caterinastelitano27@gmail.com",{"name":291,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":295,"status":116,"city":296,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":297,"geoPoint":301,"contacts":302},"Ospedale degli Infermi di Rimini, U.O. di Ematologia","Rimini",{"type":65,"coordinates":298},[299,300],12.56528,44.05755,{"lat":300,"lon":299},[303,306],{"name":304,"role":51,"phone":21,"phoneExt":21,"email":305},"Melania Celli, MD","melania.celli@auslromagna.it",{"name":304,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":308,"status":60,"city":309,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":310,"geoPoint":314,"contacts":315},"Policlinico Umberto I - Università \"La Sapienza\", Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione","Roma",{"type":65,"coordinates":311},[312,313],11.10642,44.99364,{"lat":313,"lon":312},[316,319],{"name":317,"role":51,"phone":21,"phoneExt":21,"email":318},"Ilaria Del Giudice, MD","ilaria.delgiudice@uniroma1.it",{"name":317,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":321,"status":60,"city":322,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":323,"geoPoint":327,"contacts":328},"Istituto Clinico Humanitas, U.O. Ematologia","Rozzano",{"type":65,"coordinates":324},[325,326],9.1559,45.38193,{"lat":326,"lon":325},[329,332],{"name":330,"role":51,"phone":21,"phoneExt":21,"email":331},"Francesca Ricci, MD","francesca.ricci@humanitas.it",{"name":330,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":334,"status":60,"city":335,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":336,"geoPoint":340,"contacts":341},"A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria","Torino",{"type":65,"coordinates":337},[338,339],11.99138,44.88856,{"lat":339,"lon":338},[342,344],{"name":45,"role":51,"phone":21,"phoneExt":21,"email":343},"simone.ferrero@unito.it",{"name":45,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":346,"status":60,"city":335,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":347,"geoPoint":349,"contacts":350},"A.O.U. Città della Salute e della Scienza di Torino, S.C. Ematologia",{"type":65,"coordinates":348},[338,339],{"lat":339,"lon":338},[351,354],{"name":352,"role":51,"phone":21,"phoneExt":21,"email":353},"Carola Boccomini, MD","cboccomini@cittadellasalute.to.it",{"name":352,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":356,"status":116,"city":357,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":358,"geoPoint":362,"contacts":363},"A.O. C. Panico, U.O.C Ematologia e Trapianto","Tricase",{"type":65,"coordinates":359},[360,361],18.35421,39.93018,{"lat":361,"lon":360},[364,367],{"name":365,"role":51,"phone":21,"phoneExt":21,"email":366},"Vincenzo Pavone, MD","salentoematologia@piafondazionepanico.it",{"name":365,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":369,"status":60,"city":370,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":371,"geoPoint":375,"contacts":376},"Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), SOC Clinica Ematologica","Udine",{"type":65,"coordinates":372},[373,374],13.23715,46.0693,{"lat":374,"lon":373},[377,380],{"name":378,"role":51,"phone":21,"phoneExt":21,"email":379},"Jacopo Olivieri, MD","jacopo.olivieri@asufc.sanita.fvg.it",{"name":378,"role":47,"phone":21,"phoneExt":21,"email":21},{"facility":382,"status":116,"city":383,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":384,"geoPoint":388,"contacts":389},"Ospedale di Circolo - U.O.C Ematologia","Varese",{"type":65,"coordinates":385},[386,387],8.82511,45.82058,{"lat":387,"lon":386},[390,393],{"name":391,"role":51,"phone":21,"phoneExt":21,"email":392},"Michele Merli, MD","michele.merli@asst-settelaghi.it",{"name":391,"role":47,"phone":21,"phoneExt":21,"email":21},{"type":395,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100502022",false,"NCT05816850","Multilayer Biological Characterization of Advanced Follicular Lymphoma: a Translational Study From FIL_FOLL12 Trial","FIL_FOLL-BIO","Inclusion Criteria:\n\n* Patient enrolled in the FIL\\_FOLL12 trial (documented by the signature of the study informed consent);\n* Availability of biological samples: bone marrow aspirate, peripheral blood and\u002For FFPE diagnostic sample (nodal or extranodal);\n\nExclusion Criteria:\n\n* None","ALL","18 Years",{"count":405,"type":406},654,"ESTIMATED","OBSERVATIONAL","This is a Multicenter, Retrospective, Biological study ancillary to FOLL12 trial to evaluate the role of EZH2 aberrations in patient with FL treated with immunochemotherapy. Moreover, several novel biomarkers of FL will be investigated.",[410],"Follicular Lymphoma",[412,413,414,415,416,417,418,419,420,421,422,423],"Lymphoma","Follicular","Immunochemotherapy","FL","Aberration","Mutation","EZH2","CHOP","Bendamustine","Biological","Rituximab","Biomarker","2025-12-22",{"date":426,"type":427},"2025-12-29","ACTUAL",{"date":429,"type":427},"2023-09-19",{"date":431,"type":406},"2027-06-01",{"name":5,"class":6},26]