[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659748":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":11,"studyPopulation":11,"armGroups":19,"interventions":25,"overallOfficials":11,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":11,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":11,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":68,"conditions":69,"keywords":75,"overallStatus":79,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"European Institute of Oncology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"transepidermal water loss (TEWL)",null,"Difference between baseline value and 6-month follow-up value",{"allocation":14,"interventionModel":15,"interventionModelDescription":11,"primaryPurpose":16,"observationalModel":11,"timePerspective":11,"maskingInfo":17},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":18,"maskingDescription":11,"whoMasked":11},"NONE",[20],{"label":21,"type":22,"description":11,"interventionNames":23},"skin barrier integrity assessment","EXPERIMENTAL",[24],"Diagnostic Test: skin barrier assessment",[26],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"DIAGNOSTIC_TEST","skin barrier assessment","Assessment of skin barrier integrity, quantified by transepidermal water loss (TEWL) measured under standardized conditions",[21],[32],{"name":33,"role":34,"phone":35,"phoneExt":11,"email":36},"Dario Trapani, MD","CONTACT","0257489267","dario.trapani@ieo.it",[38],{"facility":5,"status":11,"city":39,"state":40,"zip":41,"country":40,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Milan","Italy","20141","IT",{"type":44,"coordinates":45},"Point",[46,47],12.59836,42.78235,{"lat":47,"lon":46},[50],{"name":33,"role":34,"phone":35,"phoneExt":11,"email":36},{"type":52,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659748","dermatological-effects-and-quality-of-life-in-oncology-patients-100659748",false,"NCT07869186","Dermatological Effects and Quality of Life in Oncology Patients","Evaluation of Skin Alterations and Epidermal Barrier Integrity in Patients Undergoing Pharmacological Cancer Treatments (EOSIN) and Wellbeing Oncological Survey (WOS): an Integrated Approach to Assessing Dermatological Effects and Quality of Life in Oncology Patients","ReGenera","Inclusion Criteria:\n\n* Adults aged 18 years and older.\n* Patients receiving active systemic anticancer therapy with at least one of the following drug classes\u002Fregimens:\n\n  * Taxanes (e.g., paclitaxel, docetaxel) breast cancer or ovarian cancer.\n  * Neoadjuvant Pembrolizumab for stage III NSCLC\n  * Ipilimumab + nivolumab neoadjuvant for stage III and first-line metastatic treatment for patients with PD-L1 \\\u003C 1% or asymptomatic brain metastases, or after progression on BRAF and MEK inhibitors in melanoma.\n  * Nivolumab and Pembrolizumab in the adjuvant setting from stage IIB to stage III post-surgery in melanoma.\n  * Adjuvant Nivolumab also in stage IV NED (No Evidence of Disease) in melanoma.\n  * Ipilimumab in metastatic melanoma with progression on anti-PD1 therapy.\n  * Pembrolizumab, Nivolumab and Atezolizumab for Metastatic Non-Small Cell Lung Cancer (NSCLC), breast cancer and gynecological cancer\n  * Osimertinib: Adjuvant therapy in patients with common activating EGFR mutations for Non-Small Cell Lung Cancer (NSCLC) Amivantamab for advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).\n  * Pegylated liposomal doxorubicin for gynecological cancer\n* Presence at enrollment of clinically documented treatment-related dermatologic toxicity involving skin and\u002For hair and\u002For nails, defined as:\n\n  • CTCAE v5.0 grade ≥1 for at least one pre-specified dermatologic event (e.g., rash, pruritus, xerosis, erythema, pigmentary alteration, photosensitivity, paronychia\u002Fonycholysis\u002Fnail dystrophy, alopecia) as assessed by the investigators and\u002For Dermatology-confirmed treatment-related toxicity when CTCAE categorization is not fully applicable (e.g., specific nail morphology patterns).Patients must have been on the current systemic regimen for ≥1 months and ≤12 months at the time of study entry.\n* Ability and willingness to undergo instrumental skin assessments under standardized conditions.\n* Patients who provide written informed consent\n\nExclusion Criteria:\n\n* Pre-existing chronic dermatologic disease likely to confound assessment of treatment-related toxicity (e.g., psoriasis, atopic dermatitis\u002Feczema, lupus, chronic urticaria), unless clinically inactive and deemed non-confounding by the investigator\u002Fdermatologist.\n* Active skin infection at the assessment site (bacterial, viral, fungal) that may alter barrier measures.\n* Any medical or dermatologic condition that, in the investigator's judgment, may confound assessment of treatment-related skin toxicity.","ALL","18 Years",{"count":64,"type":65},300,"ESTIMATED","INTERVENTIONAL",[14],"This is a monocentric, low-risk interventional study designed to characterize established treatment-related dermatologic toxicity in patients receiving systemic anticancer therapies. The study will not modify or influence oncologic treatment decisions but will perform standardized instrumental and clinical dermatologic assessments during the course of routine cancer care.",[70,71,72,73,74],"Breast Cancer","Ovarian Cancer","NSCLC (Non-small Cell Lung Cancer)","Melanoma (Skin Cancer)","Gynecological Cancer",[76,77,78],"dermatological","oncology patient","TEWL","NOT_YET_RECRUITING","2026-10-06",{"date":82,"type":83},"2026-10-09","ACTUAL",{"date":85,"type":65},"2026-10-12",{"date":87,"type":65},"2027-10",{"name":5,"class":6},1]