[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600067":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":10,"centralContacts":41,"locations":47,"responsibleParty":189,"collaborators":10,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":10,"eligibilityCriteria":197,"healthyVolunteers":193,"sex":198,"minAge":10,"maxAge":199,"enrollmentInfo":200,"targetDuration":10,"studyType":203,"phases":10,"briefSummary":204,"conditions":205,"keywords":208,"overallStatus":137,"whyStopped":10,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},{"fullName":5,"class":6},"Intergruppo Melanoma Italiano","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A",null,"BRAF\u002FMEK inhibitors",[13],"Drug: Dabrafenib + Trametinib",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort B","Anti-PD-1",[18,19],"Drug: Pembrolizumab","Drug: Nivolumab",{"label":21,"type":10,"description":22,"interventionNames":23},"Cohort C","Observation arm",[24],"Other: Observation",[26,31,34,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"DRUG","Dabrafenib + Trametinib","There is no different use in the clinical application of the drugs reported above, the study on fertility will be implemented in the women with completely resected melanoma enrolled in the study",[9],{"type":27,"name":32,"description":29,"armGroupLabels":33,"otherNames":10},"Pembrolizumab",[15],{"type":27,"name":35,"description":29,"armGroupLabels":36,"otherNames":10},"Nivolumab",[15],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"Observation","Patients who will not initiate adjuvant therapy, but will undergo observation (due to refusal, comorbidities, other reasons).",[21],[42],{"name":43,"role":44,"phone":45,"phoneExt":10,"email":46},"Mario Mandalà","CONTACT","0039 0755784211","mario.mandala@unipg.it",[48,66,79,93,107,121,135,147,161,175],{"facility":49,"status":50,"city":51,"state":10,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Ospedale Oncologico \"Giovanni Paolo II\"","NOT_YET_RECRUITING","Bari","70122","Italy","IT",{"type":56,"coordinates":57},"Point",[58,59],16.86982,41.12066,{"lat":59,"lon":58},[62],{"name":63,"role":44,"phone":64,"phoneExt":10,"email":65},"Michele Guida","00390805555255","micguida57@gmail.com",{"facility":67,"status":50,"city":68,"state":10,"zip":10,"country":53,"countryCode":54,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"IRCCS Ospedale Policlinico San Martino, Oncologia Medica 2","Genova",{"type":56,"coordinates":70},[71,72],11.87211,45.21604,{"lat":72,"lon":71},[75],{"name":76,"role":44,"phone":77,"phoneExt":10,"email":78},"Francesco Spagnolo","00390105558104","francesco.spagnolo@hsanmartino.it",{"facility":80,"status":50,"city":81,"state":10,"zip":82,"country":53,"countryCode":54,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Fondazione IRCCS Istituto Nazionale dei Tumori","Milan","20861",{"type":56,"coordinates":84},[85,86],12.59836,42.78235,{"lat":86,"lon":85},[89],{"name":90,"role":44,"phone":91,"phoneExt":10,"email":92},"Lorenza Di Guardo","00390223902469","Lorenza.DiGuardo@istitutotumori.mi.it",{"facility":94,"status":50,"city":95,"state":10,"zip":96,"country":53,"countryCode":54,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Azienda Ospedaliero-Universitaria, Modena","Modena","41125",{"type":56,"coordinates":98},[99,100],10.92539,44.64783,{"lat":100,"lon":99},[103],{"name":104,"role":44,"phone":105,"phoneExt":10,"email":106},"Roberta Depenni","00390594222111","depenni.roberta@policlinico.mo.it",{"facility":108,"status":50,"city":109,"state":10,"zip":110,"country":53,"countryCode":54,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Istituto Nazionale Tumori \"Fondazione Pascale\"","Naples","80016",{"type":56,"coordinates":112},[113,114],14.26811,40.85216,{"lat":114,"lon":113},[117],{"name":118,"role":44,"phone":119,"phoneExt":10,"email":120},"Paolo Antonio Ascierto","00390815903841","paolo.ascierto@gmail.com",{"facility":122,"status":50,"city":123,"state":10,"zip":124,"country":53,"countryCode":54,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"IOV Istituto Oncologico Veneto","Padova","35128",{"type":56,"coordinates":126},[127,128],11.14261,44.38225,{"lat":128,"lon":127},[131],{"name":132,"role":44,"phone":133,"phoneExt":10,"email":134},"Jacopo Pigozzo","00390498215938","jacopo.pigozzo@iov.veneto.it",{"facility":136,"status":137,"city":138,"state":10,"zip":139,"country":53,"countryCode":54,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Azienda Ospedaliera Santa Maria della Misericordia - Unità di Oncologia Medica.","RECRUITING","Perugia","06132",{"type":56,"coordinates":141},[142,143],12.38878,43.1122,{"lat":143,"lon":142},[146],{"name":43,"role":44,"phone":45,"phoneExt":10,"email":46},{"facility":148,"status":50,"city":149,"state":10,"zip":150,"country":53,"countryCode":54,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","Roma","00168",{"type":56,"coordinates":152},[153,154],11.10642,44.99364,{"lat":154,"lon":153},[157],{"name":158,"role":44,"phone":159,"phoneExt":10,"email":160},"Ernesto Rossi","00390630156318","ernesto.rossi@policlinicogemelli.it",{"facility":162,"status":50,"city":163,"state":10,"zip":164,"country":53,"countryCode":54,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Università degli Studi di Siena - U.O.C. Immunoterapia Oncologica Azienda Ospedaliera Universitaria Senese","Siena","53035",{"type":56,"coordinates":166},[167,168],11.33064,43.31822,{"lat":168,"lon":167},[171],{"name":172,"role":44,"phone":173,"phoneExt":10,"email":174},"Anna Maria Di Giacomo","00390577586305","annamaria.digiacomo@unisi.it",{"facility":176,"status":50,"city":177,"state":10,"zip":178,"country":53,"countryCode":54,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Università di Torino - Clinica Dermatologica","Torino","10126",{"type":56,"coordinates":180},[181,182],11.99138,44.88856,{"lat":182,"lon":181},[185],{"name":186,"role":44,"phone":187,"phoneExt":10,"email":188},"Pietro Quaglino","00390116335849","pietro.quaglino@unito.it",{"type":190,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100600067","melafert-impact-of-adjuvant-therapy-on-fertility-in-patients-with-resected-melanoma-at-high-risk-of-relapse-100600067",false,"NCT07092670","MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse.","MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse. A Prospective Multicenter Observational Study","Inclusion Criteria:\n\n1. Stage II, III, IV completely resected melanoma\n2. Female sex\n3. Under 40 years of age\n4. Not previously treated with chemotherapy and\u002For radiotherapy\n5. Being able to give written informed consent.\n\nExclusion Criteria:\n\n1. Unresectable melanoma\n2. Predisposing conditions for infertility\n3. Early menopause or family history of early ovarian failure (idiopathic, \\\u003C 45 years)\n4. Previous bilateral ovariectomy or other ovarian surgery\n5. Personal history of autoimmune diseases, endocrine disorders (except for hypothyroidism)\n6. Personal history of severe mental disorders associated with infertility (e.g., nervous anorexia) and\u002For requiring treatments that could impair fertility\n7. Inability to give written informed consent.","FEMALE","40 Years",{"count":201,"type":202},270,"ESTIMATED","OBSERVATIONAL","Melanoma survivorship in reproductive-age women is increasing due to the advent of effective therapies in the curative setting. However, while the impact on fertility and ovarian function of chemotherapy agents is well known, there is still a lack of consistent data regarding novel the Mitogen-activated protein kinase (MAP) kinase pathway inhibitors and immune-checkpoint inhibitors (ICIs) used in melanoma.\n\nA recent study showed that a single course of anti-PD-1 (PD, Programmed cell death protein 1) or anti-CTLA-4 (Cytotoxic T-Lymphocyte Antigen 4) reduced both the number and quality of oocytes in mice through an immune-mediated mechanism. In particular, primordial follicle damage cannot be restored, leading to relevant clinical implications.\n\nThe study aims to help to determine the impact of MAP kinase pathway inhibitors and ICIs on reproductive outcomes, and whether clinicians should discuss (and in what terms) fertility preservation techniques in reproductive-age women receiving ICIs and MAP kinase pathway inhibitors in the adjuvant setting.",[206,207],"Melanoma","Fertility",[209,210,211],"MELANOMA","fertility","skin cancer","2025-09-04",{"date":214,"type":215},"2025-09-05","ACTUAL",{"date":217,"type":215},"2025-08-04",{"date":219,"type":202},"2032-08",{"name":5,"class":6},10]