protocolSection identificationModule nctId: NCT06329323, orgStudyIdInfo id: 23CX8477, briefTitle: SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours, acronym: SUMMER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-14, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, descriptionModule briefSummary: 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.The main question\[s\] it aims to answer are:1. To understand the circulating miRNA expression of malignant ovarian germ cell tumours (MOGCTs) compared to those with benign ovarian germ cell tumours (BOGCTs)2. To understand the imaging profile of MOGCTs compared to that of BOGCTs3. To establish the relationship between serum and plasma miRNA expression in response to treatment and relapse of disease4. To discover if miRNA expression correlates with radiomic features of OGCTs on both ultrasound and MRI5. 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).aimsParticipants will have serial blood tests at different time points in their care to assess how circulating miRNA levels are affected by treatment and/or remission and/or 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.Researchers 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., conditionsModule conditions: Germ Cell Ovarian Cancer, conditions: Germ Cell Tumor, conditions: Germ Cell Cancer, conditions: Germ Cell Neoplasia, conditions: Ovary Cancer, conditions: Ovary Neoplasm, conditions: Ovarian Cancer, conditions: Ovarian Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Blood test, interventions name: Pathology specimen miRNA expression, outcomesModule primaryOutcomes measure: Difference in microRNA expression (plasma) between benign and malignant masses, primaryOutcomes measure: Difference in microRNA expression (serum) between benign and malignant masses, primaryOutcomes measure: microRNA expression (plasma), primaryOutcomes measure: microRNA expression (serum), secondaryOutcomes measure: Quantitative measure of circulating miRNA before treatment, secondaryOutcomes measure: Quantitative measure of circulating miRNA before treatment, secondaryOutcomes measure: Quantitative measure of circulating miRNA after treatment, secondaryOutcomes measure: Quantitative measure of circulating miRNA after treatment, secondaryOutcomes measure: Performance of segmentation model on ultrasound images, secondaryOutcomes measure: Performance of segmentation model on MRI images, secondaryOutcomes measure: Performance of classification model on ultrasound images, secondaryOutcomes measure: Performance of classification model on MRI images, eligibilityModule sex: FEMALE, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False