[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Gynaecologisch Oncologisch Centrum Zuid\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,58],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100563046","overcoming-immunosuppression-and-rebalancing-the-immune-response-in-ovarian-cancer-study-100563046",false,"NCT06611072","OveRcoming immunosupprEssion aNd rebAlancing the Immune reSponSe in ovAriaN CancEr Study","RENAISSANCE","Inclusion Criteria:\n\n* Subjects should be at least 18 years old and mentally competent;\n* Newly diagnosed patients with OC who go for primary debulking surgery or patients with OC who are scheduled for interval debulking;\n* Controls: women who undergo surgery for benign gynaecological conditions under general anaesthesia.\n\nExclusion Criteria:\n\n* Mentally incompetent;\n* Pregnant or breastfeeding;\n* Known inflammatory of infectious diseases or an immunosuppressive status;\n* Using medication interfering with the immune system;\n* Severe comorbidities: other active malignancy (except for basal cell carcinoma and other in situ carcinomas);\n* Serious psychiatric pathology;\n* A self reported alcohol consumption of \\>21 units per week.",true,"FEMALE","18 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"NA","Ovarian cancer (OC) is one of the most lethal cancers in the world due to late-stage disease at diagnosis. Standard therapy consists of debulking surgery and chemotherapy. However, despite this aggressive treatment, recurrent disease almost invariably occurs resulting in a five-year survival rate of approximately 30%.\n\nImmunotherapy could be a way to increase survival in OC patients. However, a major barrier to a successful deployment of cancer immunotherapy for ovarian cancer patients is the immunosuppressive tumor microenvironment.\n\nEnvisioned solution\u002Fresearch direction\n\nTumor-related inflammation is one of the hallmarks of cancers in general. Innate immunity specifically is a common denominator that is involved in the pathogenesis of OC. To improve the patient's outcome and identify novel therapeutic targets, one needs a deeper understanding of the tumor-induced changes in the bone marrow myeloid progenitor cells. Furthermore, treatment of these cells by nanoparticles or other agents that induce a program of 'trained immunity' may be a novel way to re- educate myeloid cells and their bone marrow progenitors in OC patients.\n\nHypothesis\n\nWe hypothesize that by exposing myeloid cells or their progenitors to various agents that induce trained immunity (e.g. trained immunity-inducing agents: BCG, heat-killed Candida,), these immune cells will undergo functional reprogramming to induce a tumor-suppressive phenotype. In the future, this could be explored as a novel immunotherapy for tumors that are refractory to conventional treatment.\n\nObjective\n\nTo characterize and phenotype the immune state of OC patients compared to controls without cancer with a focus on the hematopoietic organs and the immune cells originating from these organs. In addition, the effect of established trained immunity-inducing agents on these cells will be evaluated in vitro, potentially providing new therapies.\n\nThis will be executed by assessing the transcriptional, epigenetic, and functional reprogramming of circulating monocytes and myeloid progenitor cells in OC and by assessing the in vitro effect of trained immunity inducers on the reprogramming of circulating monocytes and myeloid progenitor cells.\n\nStudy design: investigator-initiated, multi-center explorative cross-sectional study at the Catharina hospital Eindhoven, Radboud University Medical Center and Eindhoven University of Technology.",[27,28,29,30,31],"Ovarian Neoplasms","Ovarian Cancer","Ovarian Carcinoma","Immune Suppression","Immune System Suppression",[33,34,35,36,37,38,39,40,41,42,43,44],"Ovarian cancer","Immune system","Immune suppression","Immune system suppression","Immunotherapy","Monocytes","Myeloid cells","Vena punction","Bone marrow aspiration","Spleen biopsy","Peritoneal fluid","Tumor biopsy","RECRUITING","2025-12-05",{"date":48,"type":49},"2025-12-12","ACTUAL",{"date":51,"type":49},"2025-01-01",{"date":53,"type":21},"2027-12",{"name":55,"class":56},"Gynaecologisch Oncologisch Centrum Zuid","OTHER",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100320929","phase-2-signal-transduction-pathway-activity-analysis-in-ovarian-cancer-100320929","NCT03458221","Signal TrAnsduction Pathway Activity Analysis in OVarian cancER","STAPOVER","Inclusion Criteria:\n\n* Female, age \\> 18 years\n* Patients with recurrent ovarian cancer who meet one of the following criteria:\n* Platinum-resistant disease, defined as disease recurrence or progression within six months of last platinum-based chemotherapy or;\n* Patient refrains from standard therapy or;\n* Asymptomatic patient who is not yet eligible for standard palliative chemotherapy but has an increase of CA125 tumour marker at two consecutive time points 28 days apart with a value of two times nadir above 35 U\u002Fml.\n* Progressive disease after at least one prior line of systemic treatment for recurrent disease.\n* Radiologically evaluable disease according to RECIST 1.1 criteria (36).\n* Ability and willingness to obtain a tumour biopsy after the last course of standard treatment and before start of the study.\n* Ability and willingness to provide written and oral consent.\n* Able to speak and understand the Dutch language.\n* WHO performance status 0-II.\n* Adequate renal and liver function to start matched targeted therapy (according to the local clinician).\n* Adequate use of contraceptives in case of patients with childbearing potential.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Patient is receiving any other anti-cancer therapy (e.g. cytotoxic or targeted drug or radiation) or is chemotherapy naïve. The required wash out period prior to start of matched targeted therapy is at least three weeks.\n* Patient is diagnosed with or treated for a second primary tumour (except non-melanoma skin tumour) one year prior to study inclusion.\n* Inability to obtain (sufficient) tumour material.\n* Previous use of the selected targeted drug as anti-cancer agent.\n* Physical condition WHO III-IV.\n* Pregnant or lactating women.\n* Simultaneous participation in another treatment-related clinical trial.\n* Patients with any other clinically significant medical condition which, in the opinion of the local clinician, makes it undesirable for the patient to participate in this study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, severe psychiatric illness, or complicated social situations.",{"count":66,"type":21},148,[68,69],"PHASE2","PHASE3","The purpose of this prospective, parallel-group, cohort study is to implement phenotype-guided targeted therapy based on functional signal transduction pathway (STP) activity in recurrent ovarian cancer patients using a novel mRNA-based assay. Existing targeted drugs with tolerable toxicity profiles are used to investigate the therapeutic value beyond their approved indication, which are deemed beneficial in the select group of patients with a relevant predominantly active functional STP, in order to improve survival and maintain quality of life.",[72,73,74],"Recurrent Ovarian Cancer","Signal Transduction Pathway Deregulation","Therapy-Associated Cancer",[28,76,77,78],"Signal Transduction Pathway","Targeted therapy","Drug repurposing","2023-04-13",{"date":81,"type":49},"2023-04-18",{"date":83,"type":49},"2023-01-31",{"date":85,"type":21},"2026-10-01",{"name":55,"class":56},6,""]