[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541396":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":41,"centralContacts":46,"locations":10,"responsibleParty":55,"collaborators":10,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":10,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":80,"overallStatus":83,"whyStopped":10,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":10},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,15,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Cases- Malignant Ovarian Germ Cell Tumour - Arm 1",null,"Patients with a diagnosis of stage 1a MOGCT. Bloods taken at the following time points: Day 0, then 4 weeks; 6 months; 12 months; 24 months post-operatively",[13,14],"Diagnostic Test: Blood test","Diagnostic Test: Pathology specimen miRNA expression",{"label":16,"type":10,"description":17,"interventionNames":18},"Cases - Malignant Ovarian Germ Cell Tumour - Arm 2","Patients with a diagnosis of stage 1b\u002F1c MOGCT. Bloods taken at the following time points: Day 0, then 4 weeks; 6 months; 12 months; 24 months post-operatively OR post-final dose of adjuvant chemotherapy",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Cases - Malignant Ovarian Germ Cell Tumour - Arm 3","Patients with a diagnosis of stage 2 or higher MOGCT. Bloods taken at the following time points: Day 0, then 4 weeks post-neoadjuvant chemotherapy, then 4 weeks; 6 months; 12 months; 24 months post-operatively",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Controls - Benign Ovarian Germ Cell Tumour","Bloods taken at the time of diagnosis of BOGCT (single blood test)",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Controls - No Known Gynaecological Pathology","Single blood test",[13],[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"DIAGNOSTIC_TEST","Blood test","Serum and plasma microRNA quantification",[16,20,9,24,28],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"Pathology specimen miRNA expression","Pathology specimen mirNA expression - ALL MOGCT; OPTIONAL for BOGCT",[16,20,9,24],[42],{"name":43,"affiliation":44,"role":45},"Srdjan Saso, PhD MRCOG MRCS","Imperial College Healthcare NHS Trust","PRINCIPAL_INVESTIGATOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":10,"email":51},"Nina C Cooper, MBBS BSc","CONTACT","02033513150","nina.cooper3@nhs.net",{"name":53,"role":49,"phone":50,"phoneExt":10,"email":54},"Srdjan Saso, MRCOG Phd","srdjan.saso01@imperial.ac.uk",{"type":56,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100541396","serum-and-plasma-micrornas-in-malignant-ovarian-germ-cell-tumours-100541396",false,"NCT06329323","SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours","SUMMER","Inclusion Criteria:\n\n* All patients with a new diagnosis of a malignant ovarian germ cell tumour.\n* The control population will include all patients with a new diagnosis of a benign ovarian germ cell tumour or no known gynaecological pathology.\n\nExclusion Criteria:\n\n* Previous or ongoing chemotherapy for MOGCT\n* Previous surgery for MOGCT\n* Pregnancy - this will be verbally communicated for those not having surgery or chemotherapy, for those having surgery or chemotherapy a urine pregnancy test should be negative and documented in the clinical notes.\n* Fetal circulating DNA is known to be present in maternal blood and therefore pregnant women should not be included in this study\n* Denial of informed consent\n* Age \\\u003C16 years\n* History of any other cancer","FEMALE","16 Years",{"count":67,"type":68},24,"ESTIMATED","OBSERVATIONAL","The goal of this observational case-control study is to learn about the circulating and tissue microRNA expression, imaging and radiomic profiles of malignant ovarian germ cell tumours (MOGCT) compared to patients with a benign OGCT and no ovarian pathology.\n\nThe main question\\[s\\] it aims to answer are:\n\n1. To understand the circulating miRNA expression of malignant ovarian germ cell tumours (MOGCTs) compared to those with benign ovarian germ cell tumours (BOGCTs)\n2. To understand the imaging profile of MOGCTs compared to that of BOGCTs\n3. To establish the relationship between serum and plasma miRNA expression in response to treatment and relapse of disease\n4. To discover if miRNA expression correlates with radiomic features of OGCTs on both ultrasound and MRI\n5. To see if we can link the micro RNAs in tumour samples to those found in blood samples, and to find a plausible explanation for why these micro RNAs are raised (in terms of the tumour biology itself).aims\n\nParticipants will have serial blood tests at different time points in their care to assess how circulating miRNA levels are affected by treatment and\u002For remission and\u002For relapse. If they have surgery, a pathology sample will be taken from the main tumour specimen. Radiomic analysis will take place on existing ultrasound images of their mass.\n\nResearchers will compare the circulating miRNA profile of patients with a benign ovarian germ cell tumour and no ovarian pathology to see where the differences lie. If a patient with a BOGCT requires surgery, a pathology sample will be taken from the main tumour specimen. Radiomic analysis will take place on existing ultrasound images of their benign mass.",[72,73,74,75,76,77,78,79],"Germ Cell Ovarian Cancer","Germ Cell Tumor","Germ Cell Cancer","Germ Cell Neoplasia","Ovary Cancer","Ovary Neoplasm","Ovarian Cancer","Ovarian Neoplasms",[74,81,82,78],"microRNA","miRNA","NOT_YET_RECRUITING","2024-03-25",{"date":86,"type":87},"2024-03-26","ACTUAL",{"date":89,"type":68},"2024-04-14",{"date":91,"type":68},"2028-04",{"name":5,"class":6}]