[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506790":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":41,"responsibleParty":58,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":10,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":84,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1",null,"All patients affected by solid tumors already in treatment with anti-PD1\u002FPDL1 or cyclin-dependent kinase (CDK) inhibitors.",[13,14,15],"Other: EQ-5D-5L questionnaire","Other: FACT-G (Functional Assessment of Cancer Therapy - General)","Other: FACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)",{"label":17,"type":10,"description":18,"interventionNames":19},"Group 2","All patients affected by solid tumors already eligible for treatment with anti-PD1\u002FPDL1 or cyclin-dependent kinase (CDK) inhibitors.",[13,14,15],[21,25,28],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"EQ-5D-5L questionnaire","Quality of life evaluation questionnaire",[9,17],{"type":6,"name":26,"description":23,"armGroupLabels":27,"otherNames":10},"FACT-G (Functional Assessment of Cancer Therapy - General)",[9,17],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"FACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)","Self reported evaluation of cutaneous toxicity questionnaire.",[9,17],[33],{"name":34,"affiliation":5,"role":35},"Roberto Iacovelli","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":10,"email":40},"CONTACT","+390630157373","roberto.iacovelli@policlinicogemelli.it",[42],{"facility":34,"status":43,"city":44,"state":10,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Roma","00168","Italy","IT",{"type":49,"coordinates":50},"Point",[51,52],11.10642,44.99364,{"lat":52,"lon":51},[55,57],{"name":56,"role":38,"phone":39,"phoneExt":10,"email":40},"Roberto Iacovelli, Prof",{"name":34,"role":35,"phone":10,"phoneExt":10,"email":10},{"type":59,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100506790","evaluation-of-skin-health-and-qol-in-pts-receiving-anti-pd1pdl1ctla4-or-cdk-inhibitors-100506790",false,"NCT05878964","Evaluation of Skin Health and QoL in Pts Receiving Anti-PD1\u002FPDL1\u002FCTLA4 or CDK Inhibitors.","Evaluation of Skin Health and Quality of Life in Patients Receiving Anticancer Therapies Based on Monoclonal Antibody Anti-PD1\u002FPDL1\u002FCTLA4 or Cyclin-dependent Kinase (CDK) Inhibitors","SkinHealth","Inclusion Criteria:\n\n(for all Groups)\n\n1. Age ≥ 18 years.\n2. Histological diagnosis of solid tumor.\n3. Patient able to complete the questionnaires submitted during the study.\n4. Signed written informed consent. (for Group I) Patients already under treatment for at least three months with anti-PD1\u002FPDL1\u002F CTLA4 or cyclin-dependent kinase (CDK) inhibitors for any type of cancer. Treatment considered for each cancer are only those approved by AIFA for each tumor.\n\n(for Group II) Patients eligible for treatment with anti-PD1\u002FPDL1\u002F CTLA4 or cyclin-dependent kinase (CDK) inhibitors for any type of cancer. Treatment considered for each cancer are only those approved by AIFA for each tumor.\n\nExclusion Criteria (for all Groups):\n\n1. Age \\\u003C 18 y.o.\n2. Skin diseases or alterations present before the beginning of anti-PD1\u002FPDL1 or cyclin-dependent kinase (CDK) inhibitors.\n3. Chronic use of steroids.\n4. Previous psychiatric disorders or patients taking antidepressant.\n5. Refusal to sign written informed consent.","ALL","18 Years",{"count":71,"type":72},420,"ESTIMATED","OBSERVATIONAL","The study aim to investigate the relationship between cutaneous adverse events and quality of life in patients taking immune check point inhibitor or cyclin-dependent kinase (CDK) 4 and 6 inhibitors by two steps. In the first one, it will be investigated the relationship between the skin toxicity related to the use selected therapies and the quality of life of patients already receiving these therapies for treatment of their cancer. In the second one, it will be evaluated the relationship between skin toxicity and quality of life over three months of treatment in patients initially naïve for selected therapies. Cancer included in the analysis are NSCLC, renal cancer, gastric cancer, breast cancer, bladder cancer, melanoma, squamous cell carcinoma of the head and neck.",[76,77,78,79,80,81,82,83],"Lung Cancer","Breast Cancer","Kidney Cancer","Bladder Cancer","Gastric Cancer","Skin Cancer","Melanoma","Head Neck Cancer",[85,86,87],"immunotherapy","cyclin-dependent kinase (CDK) inhibitors","cutaneous toxicity","2024-10-03",{"date":90,"type":91},"2024-10-04","ACTUAL",{"date":93,"type":91},"2023-05-22",{"date":95,"type":72},"2025-09-22",{"name":5,"class":6},1]