[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509557":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":25,"responsibleParty":43,"collaborators":45,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":10,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":10,"enrollmentInfo":59,"targetDuration":10,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":10,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"University Hospital Tuebingen","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Control Group",null,"Chemotherapy without immunotherapy",{"label":13,"type":10,"description":14,"interventionNames":10},"Experimental Group","Chemotherapy in combination with immunotherapy",[16],{"name":17,"affiliation":18,"role":19},"Dominik Dannehl, Dr.","Department of Women's Health Tübingen","PRINCIPAL_INVESTIGATOR",[21],{"name":17,"role":22,"phone":23,"phoneExt":10,"email":24},"CONTACT","07071 29 82211","Dominik.Dannehl@med.uni-tuebingen.de",[26],{"facility":27,"status":28,"city":29,"state":10,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Department of Women's Health","RECRUITING","Tübingen","72076","Germany","DE",{"type":34,"coordinates":35},"Point",[36,37],9.05222,48.52266,{"lat":37,"lon":36},[40],{"name":41,"role":22,"phone":23,"phoneExt":10,"email":42},"Tobias Engler, Dr.","Tobias.Engler@med.uni-tuebingen.de",{"type":44,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[46,48],{"name":47,"class":6},"University Hospital Ulm",{"name":49,"class":6},"University Hospital Freiburg","100509557","immunotherapy-related-crp-kinetics-in-metastatic-gynecological-malignancies-100509557",false,"NCT05914974","Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies","ICK-Gyn: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies","Inclusion Criteria:\n\n* women ≥ 18 years of age\n* histologically proven metastatic gynecological malignancies irrespective of therapy line\n* patients with advanced or metastatic gynecological malignancies must fulfill treatment requirements for ICI therapy in the experimental group\n* planned ICI therapy in combination with palliative chemotherapy in the experimental group\n* patients with advanced or metastatic gynecological malignancies that undergo chemotherapy without ICIs in the first therapy line in the control group\n* written informed consent into ICK-Gyn\n\nExclusion Criteria:\n\n* missing indication for ICI therapy in the experimental group\n* any ICI therapy before inclusion into the trial\n* patients with advanced or metastatic endometrial or cervical cancer in the second or higher therapy line without indication to ICI therapy\n* pregnant or lactating patients\n* inadequate general condition (not fit for chemotherapy)","FEMALE","18 Years",{"count":60,"type":61},120,"ESTIMATED","OBSERVATIONAL","ICK-Gyn is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under immune checkpoint inhibitor (ICI) therapy on the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS).",[65,66,67,68,69],"Gynecological Malignancies","Cervical Cancer","Endometrial Cancer","Ovarian Cancer","Vulvar Cancer","2026-02-09",{"date":72,"type":73},"2026-02-10","ACTUAL",{"date":75,"type":73},"2023-09-11",{"date":77,"type":61},"2035-04",{"name":5,"class":6},1]