[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562697":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":10,"centralContacts":35,"locations":41,"responsibleParty":59,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":10,"enrollmentInfo":76,"targetDuration":10,"studyType":79,"phases":10,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":44,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Ospedale Policlinico San Martino","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Cases",null,"Breast cancer patients undergoing endocrine adjuvant therapy with Aromatase Inhibitors (+ GnRH analogues if they are premenopausal)",[13,14,15],"Diagnostic Test: validated questionnaires","Diagnostic Test: functional MRI","Diagnostic Test: Optical Coherent Tomography Angiography",{"label":17,"type":10,"description":18,"interventionNames":19},"Controls","Healthy age-matched women who are not using hormonal contraception or hormonal replacement therapy at the time of the study.",[13,14,15],[21,26,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DIAGNOSTIC_TEST","validated questionnaires","Validated questionnaires for climacteric symptoms",[9,17],{"type":22,"name":27,"description":27,"armGroupLabels":28,"otherNames":10},"functional MRI",[9,17],{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Optical Coherent Tomography Angiography","OCT angiography, macular and peripapillary scans",[9,17],[34],"OCT angiography",[36],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},"Claudia Massarotti, Dr","CONTACT","0039 + 0105555845","claudia.massarotti@unige.it",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"IRCCS Ospedale Policlinico San Martino","RECRUITING","Genova","GE","16132","Italy","IT",{"type":51,"coordinates":52},"Point",[53,54],11.87211,45.21604,{"lat":54,"lon":53},[57,58],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},{"name":37,"role":38,"phone":10,"phoneExt":10,"email":10},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Claudia Massarotti","Principal Investigator",[64],{"name":65,"class":6},"University of Genova","100562697","endo-brain-effects-of-endocrine-adjuvant-therapy-with-aromatase-inhibitors-on-the-cognitive-function-of-breast-cancer-patients-100562697",false,"NCT06606535","ENDO-BRAIN: Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients","ENDO-BRAIN","Inclusion Criteria:\n\n* Breast cancer patients undergoing endocrine adjuvant therapy with AI, with or without GnRH agonists, depending on menopause status at diagnosis (cases only)\n* At least 18 years old\n* Good comprehension of oral and written Italian language\n\nExclusion Criteria:\n\n* incomplete ovarian suppression (cases)\n* previous neoplastic diseases other than the presently treated breast cancer for cases\n* known neurological or psychiatric disorders\n* use of hormonal contraception or hormonal replacement therapy (controls)",true,"FEMALE","18 Years",{"count":77,"type":78},60,"ESTIMATED","OBSERVATIONAL","The principal aim of this prospective observational study is to investigate the cognitive function of breast cancer patients that use AI, comparing it with age-matched healthy controls, utilizing cognitive assessments and functional magnetic resonance imaging (fMRI). Additionally, the project seeks to establish correlations between cognitive function and other estrogen deprivation symptoms, including vasomotor symptoms, and to evaluate a possible correlation with endothelial damage studied through Angio Optical Coherent Tomography (angio OCT).\n\nPatients will be recruited during follow up visits at the iatrogenic menopause outpatient clinic. After informed consent, the will be asked for detailed demographic data, medical, oncological and gynecological history. Hypoestrogenism symptoms will be collected through validated questionnaires. The cognitive assessment will be performed on the same day, by trained staff. The fMRI and angioOCT will be booked and performed depending on patient and clinic availability.",[82,83],"Cognitive Side Effects of Cancer Therapy","Hypoestrogenism",[85,86,87,88,89],"breast cancer","cognitive side effects","hypoestrogenism","ovarian function suppression","aromatase inhibitor","2024-09-18",{"date":92,"type":93},"2024-09-23","ACTUAL",{"date":95,"type":93},"2024-06-13",{"date":97,"type":78},"2025-06-01",{"name":5,"class":6},1]