[{"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":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":30,"acronym":31,"eligibilityCriteria":32,"healthyVolunteers":28,"sex":33,"minAge":34,"maxAge":7,"enrollmentInfo":35,"targetDuration":7,"studyType":38,"phases":7,"briefSummary":39,"conditions":40,"keywords":7,"overallStatus":43,"whyStopped":7,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"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","detection-of-circulating-therapeutic-monoclonal-antibodies-in-biological-samples-of-gynecological-cancer-patients-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":36,"type":37},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.",[41,42],"Gynecological Cancer","Immunotherapy","NOT_YET_RECRUITING","2025-01-22",{"date":46,"type":47},"2025-01-28","ACTUAL",{"date":49,"type":37},"2025-03-01",{"date":51,"type":37},"2030-12-01",{"name":5,"class":6}]