[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487035":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":39,"centralContacts":44,"locations":53,"responsibleParty":72,"collaborators":10,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":10,"studyType":88,"phases":10,"briefSummary":89,"conditions":90,"keywords":10,"overallStatus":56,"whyStopped":10,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","OTHER",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Metastatic melanoma patients",null,"MDSC quantification in Metastatic melanoma patients undergoing first\u002Fsecond-line treatment with BRAF and MEK inhibitors (BRAFi+MEKi) or immune checkpoint inhibitors (antagonists of PD-1 or CTL4, or both) (n=100);",[13],"Other: MDSC quantification",{"label":15,"type":10,"description":16,"interventionNames":17},"hormone receptor positive\u002FHuman Epidermal growth factor Receptor-2 negative cancer patients","MDSC quantification in Metastatic HR+(hormone receptor positive)\u002F HER2-(Human Epidermal growth factor Receptor-2 negative) breast cancer patients already treated with a combination of an hormonal agent and a CDK(Cyclin-dependent kinase)4\u002F6 inhibitor and receiving chemotherapy (n=100);",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Advanced RCC(renal cell carcinoma) patients","MDSC quantification Advanced RCC patients receiving immune checkpoint inhibitors (antagonists of PD-1, PD-L1 or CTL4, or combinations) or anti-angiogenics alone or combined with immune checkpoint inhibitors; locally advanced\u002Fmetastatic UC(Urothelial Carcinoma) patients receiving first-line chemotherapy, immune checkpoint inhibitors or combinations (n=100);",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"SCCHN or SCC(Small Cell Carcinoma) patients","MDSC quantification in SCCHN or SCC(Small Cell Carcinoma) patients treated with first-line chemotherapy, cetuximab,immune checkpoint inhibitors or combinations (n=100).",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"NSCLC patients","MDSC quantification in NSCLC patients undergoing radical surgery for stage III cancer (n=100);patients with unresectable\u002Fmetastatic NSCLC receiving first line treatment with chemotherapy, immune checkpoint inhibitors (antagonists of PD-1, PD-L1 or CTL4) or combinations (n=100).",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Age and gender-matched healthy donors","Age and gender-matched healthy donors (n=400) will be enrolled in the study, to allow us investigating the same immunological parameters under physiological conditions and define normal values for the myeloid-related biomarkers here assessed.",[13],[35],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"MDSC quantification","Blood sample will be collected at baseline and during therapy, and, optionally, in case of disease progression (PD).",[19,31,9,27,23,15],[40],{"name":41,"affiliation":42,"role":43},"Licia Rivoltini","Fondazione IRCCS Istituto Nazionale Tumori - Milan","PRINCIPAL_INVESTIGATOR",[45,49],{"name":41,"role":46,"phone":47,"phoneExt":10,"email":48},"CONTACT","+3902\u002F23903245","licia.rivoltini@istitutotumori.mi.it",{"name":50,"role":46,"phone":51,"phoneExt":10,"email":52},"Paola Frati","+3902\u002F23903036","paola.frati@gmail.com",[54],{"facility":55,"status":56,"city":57,"state":10,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Fondazione IRCCS Istituto Nazionale dei Tumori","RECRUITING","Milan","20033","Italy","IT",{"type":62,"coordinates":63},"Point",[64,65],9.18951,45.46427,{"lat":65,"lon":64},[68,70],{"name":69,"role":46,"phone":47,"phoneExt":10,"email":48},"Licia Rivoltini, MD",{"name":50,"role":46,"phone":51,"phoneExt":10,"email":71},"paola.frati@istitutotumori.mi.it",{"type":73,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100487035","quantifying-systemic-immunosuppression-to-personalize-cancer-therapy-100487035",false,"NCT05621837","Quantifying Systemic Immunosuppression to Personalize Cancer Therapy","Serpentine","Inclusion Criteria\n\n* Histologically documented diagnosis of metastatic\u002Flocally advanced melanoma, hormone-refractory breast cancer, RCC and UC, SCCHN, SCC or NSCLC, stage III resectable NSCLC will also be included\n* Will and ability to comply with the protocol\n* Willingness and ability to provide an adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumor sample available for exploratory biomarker analysis\n* Age from 18 to 90 years at the time of recruitment\n* ECOG Performance Status \\\u003C= 2\n* Understanding and signature of the informed consent\n* Consenting to participate to the socio-economical-psychological survey\n\nExclusion Criteria\n\n* Known history of HIV infection\n* Serious neurological or psychiatric disorders\n* Pregnancy or lactation\n* Inability or unwillingness of participant to give written informed consent\n* Inability or unwillingness to be regularly followed up at the same center",true,"ALL","18 Years","90 Years",{"count":86,"type":87},1000,"ESTIMATED","OBSERVATIONAL","The Serpentine (Stratify cancER PatiENTs by ImmuNosupprEssion) project, represents the most consistent effort so far attempted to translate MDSC into clinical practise by producing an off-the-shelf compliant assay for quantifying these cells in peripheral blood.",[91,92,93,94,95,96,97],"Melanoma","Breast Cancer","Renal Cell Carcinoma","Urinary Bladder Cancer","Squamous Cell Carcinoma of Head and Neck","Small Cell Carcinoma","NSCLC","2025-04-29",{"date":100,"type":101},"2025-05-02","ACTUAL",{"date":103,"type":101},"2022-03-10",{"date":105,"type":87},"2026-12-31",{"name":5,"class":6},1]