[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499931":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":16,"centralContacts":20,"locations":25,"responsibleParty":43,"collaborators":46,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":7,"enrollmentInfo":71,"targetDuration":7,"studyType":74,"phases":7,"briefSummary":75,"conditions":76,"keywords":7,"overallStatus":28,"whyStopped":7,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Regina Elena Cancer Institute","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DRUG","Lenvatinib","Patients will be treated by lenvatinib as recommended by good clinical practice",[14,15],"lenvatinib mesilate","Lenvatinib Oral Capsule [Lenvima]",[17],{"name":18,"affiliation":5,"role":19},"Marialuisa Appetecchia, Prof","PRINCIPAL_INVESTIGATOR",[21],{"name":18,"role":22,"phone":23,"phoneExt":7,"email":24},"CONTACT","00390652666026","marialuisa.appetecchia@ifo.it",[26],{"facility":27,"status":28,"city":29,"state":7,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Regina Elena National Cancer Institute","RECRUITING","Rome","00144","Italy","IT",{"type":34,"coordinates":35},"Point",[36,37],12.51133,41.89193,{"lat":37,"lon":36},[40],{"name":41,"role":22,"phone":42,"phoneExt":7,"email":24},"Marialuisa Appetecchia, MD","0039 0652666026",{"type":19,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Marialuisa Appetecchia","Professor",[47,49,51,53,55,57,59],{"name":48,"class":6},"University of Turin, Italy",{"name":50,"class":6},"University of Roma La Sapienza",{"name":52,"class":6},"University of Siena",{"name":54,"class":6},"University of Pisa",{"name":56,"class":6},"Istituto Oncologico Veneto IRCCS",{"name":58,"class":6},"University of Catania",{"name":60,"class":6},"Istituto Auxologico Italiano","100499931","gender-based-impact-on-safety-and-efficacy-of-lenvatinib-in-patients-with-differentiated-thyroid-cancer-100499931",false,"NCT05789667","Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Differentiated Thyroid Cancer","Observational Study on Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Radioiodine Refractory Differentiated Thyroid Cancer","Gisel","Inclusion Criteria:\n\n* Patients with refractory iodine DTC treated with lenvatinib\n* Signed written informed consent\n\nExclusion Criteria:\n\n\\- Age \\\u003C 18 years","ALL","18 Years",{"count":72,"type":73},50,"ESTIMATED","OBSERVATIONAL","Lenvatinib is approved for the treatment of radioiodine refractory differentiated thyroid cancer. Despite gender can play a crucial role un in safety and efficacy of oncological product, little is know on gender difference in lenvatinb effacacy and safety in the context of radioiodine refractory differentiated thyroid cancer.\n\nThe primary objective of the study is to assess safety and toxicity profile in male and female patients in terms of dose reduction. The secondary objectives are to assess sex and gender difference in: the number and the incidence of adverse events; response rate according to RECIST criteria 1.1; progression free survival, overall survival and duration of response.",[77,78],"Differentiated Thyroid Cancer","Gender","2024-12-05",{"date":81,"type":82},"2024-12-06","ACTUAL",{"date":84,"type":82},"2020-05-27",{"date":86,"type":73},"2025-12-31",{"name":5,"class":6},1]