[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583067":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":47,"studyPopulation":48,"armGroups":49,"interventions":44,"overallOfficials":44,"centralContacts":56,"locations":68,"responsibleParty":428,"collaborators":44,"id":430,"slug":431,"hasResults":432,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":432,"sex":438,"minAge":439,"maxAge":44,"enrollmentInfo":440,"targetDuration":44,"studyType":443,"phases":44,"briefSummary":444,"conditions":445,"keywords":447,"overallStatus":449,"whyStopped":44,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":459},{"fullName":5,"class":6},"Consorzio Oncotech","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":44},[9,13,16,18,20],{"measure":10,"description":11,"timeFrame":12},"Establishment of a prospective Italian observational registry for the implementation of genomic tests in patients with HR +\u002FHER2- breast cancer","Establishment of a prospective Italian observational registry for the implementation of genomic tests in patients with HR +\u002FHER2- breast cancer at intermediate risk of recurrence after the adoption of the Ministerial Decree of 18\u002F05\u002F2021","Until November 2026",{"measure":14,"description":15,"timeFrame":12},"Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only)","Rate of adjuvant treatment choice's change following the genomic test result (Breast Unit's pre-test vs post-test indication)",{"measure":14,"description":17,"timeFrame":12},"Saving in adjuvant chemotherapy compared to the pre-test indication",{"measure":14,"description":19,"timeFrame":12},"Addition of adjuvant chemotherapy to endocrine therapy alone compared to the pre-test indication",{"measure":14,"description":21,"timeFrame":12},"Type of adjuvant treatment the patient actually received",[23,25,27,29,32,35,38,40,42],{"measure":24,"description":24,"timeFrame":12},"Record the predominant demographic and clinical characteristics of the patients for whom genomic testing was indicated.",{"measure":26,"description":26,"timeFrame":12},"Describe which genomic tests are used and the factors involved in the selection of genomic tests.",{"measure":28,"description":28,"timeFrame":12},"Identify any inequalities in access to the genomic tests in different geographical areas of the country.",{"measure":30,"description":31,"timeFrame":12},"Analyse the prescriptive adequacy and the compliance","With the inclusion criteria for genomic tests.",{"measure":33,"description":34,"timeFrame":12},"Record the distribution of demographic and clinical characteristics in the group of patients with changed treatment recommendation compared to the group of patients with unchanged indication after genomic test.","patient age comorbidities, tumour size, number of positive lymph nodes, tumour grade",{"measure":36,"description":37,"timeFrame":12},"Evaluate the impact of the test on the timing of activation of adjuvant treatment","Time from diagnosis to request for genomic test",{"measure":36,"description":39,"timeFrame":12},"Time from request for the genomic test to result",{"measure":36,"description":41,"timeFrame":12},"Time from test result to activation of adjuvant chemotherapy, if indicated",{"measure":36,"description":43,"timeFrame":12},"Time from diagnosis to activation of adjuvant chemotherapy, if indicated",null,{"allocation":44,"interventionModel":44,"interventionModelDescription":44,"primaryPurpose":44,"observationalModel":46,"timePerspective":6,"maskingInfo":44},"COHORT","The study is a retrospective and prospective, non-interventional, observational registry-based study that will enroll all patients with ER +\u002FHER2-negative, T1-3 breast cancer with negative axillary lymph nodes or up to 3 positive axillary lymph nodes for whom Breast Units require genomic test to support adjuvant therapy decisions, according to current clinical practice. For prospective cohort: genomic tests will be performed on all patients who meet the criteria for access to testing as set out in the Ministerial Decree of 18\u002F05\u002F2021, unless otherwise agreed by the reference Breast Unit, in accordance with the specific diagnostic pathways activated by each site. For retrospective cohort: data for patient referred for genomic testing following Ministerial Decree 18\u002F05\u002F2021 will be collected. The patient's baseline demographic characteristics, tumor clinicopathological features, pre and post-test therapeutic indication (CET vs ET), the test results, the actual adjuvant treatment received and time around data will be recorded in a dedicated registry.","The study is a retrospective and prospective, non-interventional, observational registry-based study that will enroll all patients with ER +\u002FHER2-negative, T1-3 breast cancer with negative axillary lymph nodes or up to 3 positive axillary lymph nodes for whom Breast Units require genomic test to support adjuvant therapy decisions, according to current clinical practice.",[50,53],{"label":51,"type":44,"description":52,"interventionNames":44},"Prospective cohort","For prospective cohort: genomic tests will be performed on all patients who meet the criteria for access to testing as set out in the Ministerial Decree of 18\u002F05\u002F2021, unless otherwise agreed by the reference Breast Unit, in accordance with the specific diagnostic pathways activated by each site.",{"label":54,"type":44,"description":55,"interventionNames":44},"Retrospective cohort","For retrospective cohort: data for patient referred for genomic testing following Ministerial Decree 18\u002F05\u002F2021 will be collected. The retrospective cohort will contribute to expanding our knowledge of the clinico-pathological characteristics of patients who underwent genomic testing. This comprehensive understanding of the clinico-pathological profile of patients undergoing genomic testing will enable a more thorough assessment of the clinical dynamics and therapeutic decisions associated with genomic testing results, including the analysis of their possible evolution over the years.",[57,63],{"name":58,"role":59,"phone":60,"phoneExt":61,"email":62},"Mario G Mario Giuliano, MD","CONTACT","0817463762","3762","m.giuliano@unina.it",{"name":64,"role":59,"phone":65,"phoneExt":66,"email":67},"GIM29-GIMOMIC S GIM29-GIMOMIC Service","+39 089301545","1545","helpdesk.gim29@oncotech.org",[69,88,104,120,134,148,164,180,196,212,228,244,254,267,283,299,309,325,341,357,370,381,389,400,415],{"facility":70,"status":44,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"A.O. San Giuseppe Moscati","Avellino","AV","83100","Italy","IT",{"type":77,"coordinates":78},"Point",[79,80],14.79103,40.91494,{"lat":80,"lon":79},[83],{"name":84,"role":59,"phone":85,"phoneExt":86,"email":87},"Giuseppe C Giuseppe Colantuoni, MD","0825203945","3945","gicolantuoni@gmail.com",{"facility":89,"status":44,"city":90,"state":91,"zip":92,"country":74,"countryCode":75,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Ospedale Papa Giovanni XXIII","Bergamo","BG","24127",{"type":77,"coordinates":94},[95,96],9.66721,45.69601,{"lat":96,"lon":95},[99],{"name":100,"role":59,"phone":101,"phoneExt":102,"email":103},"Elena RC Elena Rota Caremoli, MD","0352673694","3694","ecrota@asst-pg23.it",{"facility":105,"status":44,"city":106,"state":107,"zip":108,"country":74,"countryCode":75,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Policlinico S. Orsola-Malpighi","Bologna","BO","40138",{"type":77,"coordinates":110},[111,112],11.33875,44.49381,{"lat":112,"lon":111},[115],{"name":116,"role":59,"phone":117,"phoneExt":118,"email":119},"Claudio Z Claudio Zamagni, MD","0512144548","4548","zamagniclaudio.sper@aosp.bo.it",{"facility":121,"status":44,"city":122,"state":123,"zip":124,"country":74,"countryCode":75,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Spedali Civili di Brescia","Brescia","BS","25123",{"type":77,"coordinates":126},[127,128],10.21472,45.53558,{"lat":128,"lon":127},[131],{"name":132,"role":59,"phone":44,"phoneExt":44,"email":133},"Rebecca P Rebecca Pedersini, MD","rebecca.pedersini@gmail.com",{"facility":135,"status":44,"city":136,"state":137,"zip":138,"country":74,"countryCode":75,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Asrem - Azienda Sanitaria Regionale del Molise","Termoli","CB","86039",{"type":77,"coordinates":140},[141,142],14.99389,41.99994,{"lat":142,"lon":141},[145],{"name":146,"role":59,"phone":44,"phoneExt":44,"email":147},"Francesco C Francesco Carrozza, MD","francesco.carrozza@asrem.molise.it",{"facility":149,"status":44,"city":150,"state":151,"zip":152,"country":74,"countryCode":75,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Azienda Ospedaliera\" Sant'Anna e San Sebastiano\"","Caserta","CE","81100",{"type":77,"coordinates":154},[155,156],14.33231,41.07262,{"lat":156,"lon":155},[159],{"name":160,"role":59,"phone":161,"phoneExt":162,"email":163},"Michele O Michele Orditura, MD","0823232515","2515","michele.orditura@aorncaserta.it",{"facility":165,"status":44,"city":166,"state":167,"zip":168,"country":74,"countryCode":75,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Azienda Ospedaliera S. Croce e Carle","Cuneo","CN","12100",{"type":77,"coordinates":170},[171,172],7.54828,44.39071,{"lat":172,"lon":171},[175],{"name":176,"role":59,"phone":177,"phoneExt":178,"email":179},"Anna Maria V Anna Maria Vandone, MD","0171616350","6350","vandone.a@ospedale.cuneo.it",{"facility":181,"status":44,"city":182,"state":183,"zip":184,"country":74,"countryCode":75,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Azienda Ospedaliero-Universitaria Arcispedale S. Anna","Ferrara","FE","44124",{"type":77,"coordinates":186},[187,188],11.62057,44.83804,{"lat":188,"lon":187},[191],{"name":192,"role":59,"phone":193,"phoneExt":194,"email":195},"Alessio S Alessio Schirone, MD","0532236167","6167","a.schirone@ospfe.it",{"facility":197,"status":44,"city":198,"state":199,"zip":200,"country":74,"countryCode":75,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Azienda Ospedaliera Universitaria Careggi","Florence","FI","50134",{"type":77,"coordinates":202},[203,204],11.24626,43.77925,{"lat":204,"lon":203},[207],{"name":208,"role":59,"phone":209,"phoneExt":210,"email":211},"Icro M Icro Meattini, MD","0552751828","1828","icro.meattini@unifi.it",{"facility":213,"status":44,"city":214,"state":215,"zip":216,"country":74,"countryCode":75,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"IRCCS Ospedale Policlinico San Martino","Genova","GE","16132",{"type":77,"coordinates":218},[219,220],11.87211,45.21604,{"lat":220,"lon":219},[223],{"name":224,"role":59,"phone":225,"phoneExt":226,"email":227},"Davide S. Davide Soldato, MD","0105557300","7300","davide.soldato@hsanmartino.it",{"facility":229,"status":44,"city":230,"state":231,"zip":232,"country":74,"countryCode":75,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"IRCCS Ospedale San Raffaele","Milan","MI","20132",{"type":77,"coordinates":234},[235,236],12.59836,42.78235,{"lat":236,"lon":235},[239],{"name":240,"role":59,"phone":241,"phoneExt":242,"email":243},"Luca L Luca Licata, MD","0226436530","6530","licata.luca@hsr.it",{"facility":245,"status":44,"city":230,"state":231,"zip":246,"country":74,"countryCode":75,"cosmosGeoPoint":247,"geoPoint":249,"contacts":250},"Istituto Europeo di Oncologia","20141",{"type":77,"coordinates":248},[235,236],{"lat":236,"lon":235},[251],{"name":252,"role":59,"phone":44,"phoneExt":44,"email":253},"Giuseppe C Giuseppe Curigliano, MD","giuseppe.curigliano@ieo.it",{"facility":255,"status":44,"city":256,"state":231,"zip":257,"country":74,"countryCode":75,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"IRCCS Humanitas Research Hospital","Rozzano","20089",{"type":77,"coordinates":259},[260,261],9.1559,45.38193,{"lat":261,"lon":260},[264],{"name":265,"role":59,"phone":44,"phoneExt":44,"email":266},"Alberto Z Alberto Zambelli, MD","alberto.zambelli@hunimed.eu",{"facility":268,"status":44,"city":269,"state":270,"zip":271,"country":74,"countryCode":75,"cosmosGeoPoint":272,"geoPoint":276,"contacts":277},"IRCCS Centro di Riferimento Oncologico (C.R.O.)","Aviano","PD","33081",{"type":77,"coordinates":273},[274,275],12.59472,46.07056,{"lat":275,"lon":274},[278],{"name":279,"role":59,"phone":280,"phoneExt":281,"email":282},"Fabio P Fabio Puglisi, MD","0434659253","9253","fabio.puglisi@cro.it",{"facility":284,"status":44,"city":285,"state":286,"zip":287,"country":74,"countryCode":75,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"Ospedale S. Stefano","Prato","PO","59100",{"type":77,"coordinates":289},[290,291],11.09699,43.8805,{"lat":291,"lon":290},[294],{"name":295,"role":59,"phone":296,"phoneExt":297,"email":298},"Laura B Laura Biganzoli, MD","0574802531","2531","laura.biganzoli@uslcentro.toscana.it",{"facility":300,"status":44,"city":301,"state":302,"zip":303,"country":74,"countryCode":75,"cosmosGeoPoint":304,"geoPoint":308,"contacts":44},"Azienda USL IRCCS di Reggio Emilia","Reggio Emilia","RE","42123",{"type":77,"coordinates":305},[306,307],10.63125,44.69825,{"lat":307,"lon":306},{"facility":310,"status":44,"city":311,"state":312,"zip":313,"country":74,"countryCode":75,"cosmosGeoPoint":314,"geoPoint":318,"contacts":319},"Istituto Nazionale Tumori Regina Elena","Roma","RM","00144",{"type":77,"coordinates":315},[316,317],11.10642,44.99364,{"lat":317,"lon":316},[320],{"name":321,"role":59,"phone":322,"phoneExt":323,"email":324},"Paola M Paola Malaguti, MD","0652666771","6771","paola.malaguti@ifo.it",{"facility":326,"status":44,"city":327,"state":328,"zip":329,"country":74,"countryCode":75,"cosmosGeoPoint":330,"geoPoint":334,"contacts":335},"Ospedale Infermi di Rimini","Rimini","RN","47923",{"type":77,"coordinates":331},[332,333],12.56528,44.05755,{"lat":333,"lon":332},[336],{"name":337,"role":59,"phone":338,"phoneExt":339,"email":340},"Lorenzo G Lorenzo Gianni, MD","0541705413","5413","lorenzo.gianni@auslromagna.it",{"facility":342,"status":44,"city":343,"state":344,"zip":345,"country":74,"countryCode":75,"cosmosGeoPoint":346,"geoPoint":350,"contacts":351},"Ospedale San Bortolo di Vicenza","Vicenza","VI","36100",{"type":77,"coordinates":347},[348,349],11.5475,45.54672,{"lat":349,"lon":348},[352],{"name":353,"role":59,"phone":354,"phoneExt":355,"email":356},"Lucia B Lucia Borgato, MD","0444753836","3836","lucia.borgato@aulss8.veneto.it",{"facility":358,"status":44,"city":359,"state":44,"zip":360,"country":74,"countryCode":75,"cosmosGeoPoint":361,"geoPoint":365,"contacts":366},"A.O.R.N. \"A. Cardarelli\"","Naples","80131",{"type":77,"coordinates":362},[363,364],14.26811,40.85216,{"lat":364,"lon":363},[367],{"name":368,"role":59,"phone":44,"phoneExt":44,"email":369},"Ferdinando R Ferdinando Riccardi, MD","ferdinando.riccardi@aocardarelli.it",{"facility":371,"status":44,"city":359,"state":44,"zip":360,"country":74,"countryCode":75,"cosmosGeoPoint":372,"geoPoint":374,"contacts":375},"AORN - Ospedali dei Colli",{"type":77,"coordinates":373},[363,364],{"lat":364,"lon":363},[376],{"name":377,"role":59,"phone":378,"phoneExt":379,"email":380},"Vincenzo M Vincenzo Montesarchio, MD","0817062855","2855","vincenzo.montesarchio@ospedalideicolli.it",{"facility":382,"status":44,"city":359,"state":44,"zip":360,"country":74,"countryCode":75,"cosmosGeoPoint":383,"geoPoint":385,"contacts":386},"Azienda Ospedaliero Universitaria Federico II",{"type":77,"coordinates":384},[363,364],{"lat":364,"lon":363},[387],{"name":58,"role":59,"phone":388,"phoneExt":61,"email":62},"081 746 3762",{"facility":390,"status":44,"city":359,"state":44,"zip":360,"country":74,"countryCode":75,"cosmosGeoPoint":391,"geoPoint":393,"contacts":394},"Istituto Nazionale Tumori IRCCS Fondazione Pascale",{"type":77,"coordinates":392},[363,364],{"lat":364,"lon":363},[395],{"name":396,"role":59,"phone":397,"phoneExt":398,"email":399},"Michelino DL Michelino De Laurentiis, MD","08117770432","0432","delauren@breastunit.org;m.delaurentiis@istitutotumori.na.it",{"facility":401,"status":44,"city":402,"state":44,"zip":403,"country":74,"countryCode":75,"cosmosGeoPoint":404,"geoPoint":408,"contacts":409},"A.O.U. Maggiore della Carità di Novara","Novara","28100",{"type":77,"coordinates":405},[406,407],8.62118,45.44694,{"lat":407,"lon":406},[410],{"name":411,"role":59,"phone":412,"phoneExt":413,"email":414},"Alessandra G Alessandra Gennari, MD","03213732296","2296","alessandra.gennari@uniupo.it",{"facility":416,"status":44,"city":417,"state":44,"zip":418,"country":74,"countryCode":75,"cosmosGeoPoint":419,"geoPoint":423,"contacts":424},"P.O.\"Santa Maria delle Grazie\" di Pozzuoli","Pozzuoli","80078",{"type":77,"coordinates":420},[421,422],14.0952,40.84394,{"lat":422,"lon":421},[425],{"name":426,"role":59,"phone":44,"phoneExt":44,"email":427},"Angela R Angela Ruggiero, MD","angela.ruggiero@aslnapoli2nord.it",{"type":429,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100583067","observational-retrospective-and-prospective-non-interventional-multicentre-on-the-use-of-genomic-testing-in-the-management-of-early-stage-hrher2--breast-cancer-100583067",false,"NCT06871501","\"Observational, Retrospective and Prospective, Non-interventional, Multicentre on the Use of Genomic Testing in the Management of Early Stage HR+\u002FHER2- Breast Cancer\"","\"Observational, Retrospective and Prospective, Non-interventional, Multicentre National Registry-based Study to Collect Information on the Use of Genomic Testing in the Management of Early Stage HR+\u002FHER2- Breast Cancer\"","GIM29-GIMOMIC","Inclusion Criteria:\n\n1. . Age ≥ 18 years\n2. PS ECOG 0-1\n3. Histologically confirmed early breast carcinoma with positivity for hormone receptors (ER+ IHC \\>10%) and HER2 negative (IHC value 0 1+ and\u002For FISH not-amplified)\n4. Primary resective surgery for early breast cancer with adequate assessment of lymph node status (sentinel lymph node biopsy or complete axillary dissection), with one of the following diagnostic stages:\n\n   * T1-3, N0, M0\n   * T1-3, pN1mic, M0\n   * T1-3, pN1a, M0\n5. Indication for adjuvant treatment with endocrine therapy (ET) or chemo endocrine therapy (CET), according to the decision of the reference Breast Unit\n6. Meeting the criteria for \"intermediate\" risk, i.e., no \"low\" or \"high\" risk of recurrence, as defined in the ministerial decree of 18\u002F05\u002F21:\n\n   * Low risk defined by at least 5 of the following: G1, T1a-b, KI67 \\\u003C 15, N neg, ER \\> 80%\n   * High risk, defined by at least 4 of the following: G3, T \\> 2, Ki67 \\> 30, N pos, ER \\\u003C 30%\n7. Indication for genomic test (Oncotype DX®, Mammaprint®, PAM50 Prosigna®, Breast Cancer Index®, EndoPredict®) by the Breast Unit\n8. Ability to provide written informed consent to participate in the registry study, approved by the local Ethics Committee.\n9. The patient underwent genomic testing starting from September 2021\n\nExclusion Criteria:\n\n1. Low-risk and High-risk patients as defined in the Ministerial Decree of 18\u002F05\u002F21\n2. ER negative and\u002For HER2 positive tumours\n3. More than 3 lymph nodes involved at clinical\u002Fpathological staging\n4. Invasive tumours \\\u003C2mm evaluated by local pathologists\n5. Previous history of breast cancer\n6. Synchronous breast cancers\n7. Multifocal tumours\n8. Metastatic disease\n9. Contraindications to adjuvant treatments\n10. Performance status (PS ECOG) \\> 1 and \u002F or other clinical factors that would make the patient a candidate and unsuitable for systemic adjuvant treatment or have received an exclusive indication for precautionary hormone therapy as part of the Breast Unit collegial assessment.\n11. Psychiatric diagnosis that may affect the ability to participate in this study","ALL","18 Years",{"count":441,"type":442},1000,"ESTIMATED","OBSERVATIONAL","The study aims to establish an Italian registry for the implementation of the use of genomic tests in patients with HR +\u002FHER2- breast cancer at intermediate risk of recurrence after the entry into force of the Ministerial Decree of 18\u002F05\u002F2021. The decree has established the reimbursability of genomic testing for breast cancer patients, thereby influencing clinical decision-making and patient management within Breast Units. In addition, the study aims to evaluate the clinical impact of the use of genomic testing on the type of adjuvant treatment, in terms of change of treatment indication by breast units according to the test result.",[446],"Breast Cancer",[446,448],"Genomic testing","NOT_YET_RECRUITING","2025-03-11",{"date":452,"type":453},"2025-03-13","ACTUAL",{"date":455,"type":442},"2025-03",{"date":457,"type":442},"2026-11",{"name":5,"class":6},25]