[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577375":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":17,"locations":7,"responsibleParty":23,"collaborators":7,"id":26,"slug":7,"hasResults":27,"nctId":28,"briefTitle":29,"officialTitle":29,"acronym":30,"eligibilityCriteria":31,"healthyVolunteers":27,"sex":32,"minAge":33,"maxAge":7,"enrollmentInfo":34,"targetDuration":7,"studyType":37,"phases":7,"briefSummary":38,"conditions":39,"keywords":7,"overallStatus":42,"whyStopped":7,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":7},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"PROCEDURE","Blood samples for the analysis of sildenafil in plasma","To detect the ICI mAbs in patients' blood plasma samples, we select three anti PD-1 mAbs (cemiplimab, dostarlimab and pembrolizumab) as prognostic biomarkers which will be quantified using different biochemical\u002Fanalytical assays.",[14],{"name":15,"affiliation":5,"role":16},"Giovanni Scambia","PRINCIPAL_INVESTIGATOR",[18],{"name":19,"role":20,"phone":21,"phoneExt":7,"email":22},"Giovanni Scambia, PhD","CONTACT","+390630155701","giovanni.scambia@policlinicogemelli.it",{"type":16,"investigatorFullName":24,"investigatorTitle":25,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"SCAMBIA GIOVANNI","Professore","100577375",false,"NCT06797479","Detection of Circulating Therapeutic Monoclonal Antibodies in Biological Samples of Gynecological Cancer Patients.","IMMUNO_ASSAY","Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of gynecological malignancy;\n* Patients currently undergoing or scheduled to undergo immunotherapy as part of their treatment regimen;\n* Age \\> 18 years;\n* Patients who are able and willing to provide written informed consent to participate in the study.\n* Availability of biological samples.\n\nExclusion Criteria:\n\n* Patients receiving concurrent treatment with other investigational drugs or therapies that may interfere with immunotherapy.\n* Presence of significant comorbidities or other medical conditions that, in the opinion of the investigator, would interfere with study participation or interpretation of results (e.g., severe autoimmune diseases, uncontrolled infections);\n* Pregnant or breastfeeding women;\n* Patients who have received prior monoclonal antibody therapy that could affect the study results;\n* Patients who are unable or unwilling to comply with the study procedures and follow-up requirements;\n* Brain metastases;\n* History of other malignancies within the last 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.","FEMALE","18 Years",{"count":35,"type":36},12,"ESTIMATED","OBSERVATIONAL","Quantification of anti PD-1 mAbs in cancer patients is extremely important to monitor pharmacokinetics and effectiveness of immunotherapy. To detect the ICI mAbs in patients' blood plasma samples, we select three anti PD-1 mAbs (cemiplimab, dostarlimab and pembrolizumab) as prognostic biomarkers which will be quantified using different biochemical\u002Fanalytical assays.",[40,41],"Gynecological Cancer","Immunotherapy","NOT_YET_RECRUITING","2025-01-22",{"date":45,"type":46},"2025-01-28","ACTUAL",{"date":48,"type":36},"2025-03-01",{"date":50,"type":36},"2030-12-01",{"name":5,"class":6}]