[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569388":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":32,"locations":41,"responsibleParty":58,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":75,"studyType":76,"phases":10,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":44,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Surgical management",null,"Patients aged ≤ 20 years of age recommended for surgery at that visit due to a suspicion of malignancy or pain.",[13],"Procedure: Group 1: Surgical management",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2: Conservative management (follow-up)","Patients aged ≤ 20 not recommended for surgery due to suspicion of malignancy\u002Fcomplications, for which subjective impression was benign for all visits, and for which the tumour was still present at the next visit.",[18],"Diagnostic Test: Group 2: Conservative management (follow-up)",[20,26],{"type":21,"name":15,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","A standardised transabdominal examination is performed, including color or power Doppler examination. Transvaginal ultrasonography can be performed in sexually active adolescents with consent. Transrectal examination is also acceptable for younger patients who are not sexually active. All the variables required for the Simple Rules, simple descriptors and ADNEX model are assessed.\n\nBefore entering ultrasound information about the tumour and getting model results, the ultrasound examiner' s diagnosis (benign, borderline, malignant; specific diagnosis) based on subjective assessment is recorded. Results based on Simple Rules, simple descriptors and ADNEX model are documented as well.\n\nIf the adnexal mass is seen and if the decision is to manage the adnexal mass conservatively, the patient will be re-scanned at 6 weeks (maximal range 6-8 weeks), 3 months (+\u002F- 2 weeks) and 12 months (maximal range 10-14 months)",[15],[25],"Ultrasound Assessment",{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","A standardised transabdominal examination is performed, including color or power Doppler examination. Transvaginal ultrasonography can be performed in sexually active adolescents with consent. Transrectal examination is also acceptable for younger patients who are not sexually active. All the variables required for the Simple Rules, simple descriptors and ADNEX model are assessed.\n\nBefore entering ultrasound information about the tumour and getting model results, the ultrasound examiner' s diagnosis (benign, borderline, malignant; specific diagnosis) based on subjective assessment is recorded. Results based on Simple Rules, simple descriptors and ADNEX model are documented as well.\n\nIf the patient requires surgery, no further ultrasound scans will be required.",[9],[31],"Surgery",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Dirk Timmerman, Prof.","CONTACT","+3216344202","iota@uzleuven.be",{"name":39,"role":35,"phone":40,"phoneExt":10,"email":37},"Wouter Froyman, Prof.","3216344202",[42],{"facility":43,"status":44,"city":45,"state":10,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"UZ Leuven","RECRUITING","Leuven","3000","Belgium","BE",{"type":50,"coordinates":51},"Point",[52,53],4.70093,50.87959,{"lat":53,"lon":52},[56],{"name":57,"role":35,"phone":40,"phoneExt":10,"email":37},"Dirk Timmerman",{"type":59,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100569388","masses-in-young-patients---international-ovarian-tumour-analysis-my-iota-100569388",false,"NCT06693596","Masses in Young Patients - International Ovarian Tumour Analysis (MY-IOTA)","Masses in Young Patients - International Ovarian Tumour Analysis: Prospective Validation and Comparison of Simple Rules, Benign Descriptors and ADNEX Models for Discrimination Between Benign and Malignant Adnexal Masses in Young Girls and Adolescents MY-IOTA","MY-IOTA","• Inclusion Criteria:\n\nAll newly diagnosed adnexal masses identified in a girl or adolescent aged 20 or under.\n\n• Exclusion Criteria:\n\nParticipants eligible for this study must not meet any of the following criteria:\n\n* Non-adnexal masses e.g. peritoneal inclusion cysts (where diagnosis is certain) and peritoneal carcinomatosis with no adnexal mass;\n* The denial or withdrawal of written informed consent.\n* Pregnancy at any timepoint during the study period\n* In premenarchal participants: follicle measuring \\\u003C10mm",true,"FEMALE","0 Years","20 Years",{"count":73,"type":74},1000,"ESTIMATED","2 Years","OBSERVATIONAL","This multicenter observational study aims to validate the IOTA Simple Rules, Benign Descriptors, and ADNEX model in a cohort of patients equal or under the age of 20. Moreover, the study aims to evaluate the diagnostic accuracy of subjective assessment by ultrasound and to analyze the rate of complications in patients treated conservatively.",[79,80,81,82],"Adnexal Mass","Adnexal Tumor","Adnexal Cyst","Adnexal Masses in Young Girls and Adolescents",[84,85,86,87,88],"IOTA","ovarian mass","benign","malignant","Young patients","2024-11-14",{"date":91,"type":92},"2024-11-18","ACTUAL",{"date":94,"type":74},"2024-11-20",{"date":96,"type":74},"2026-09-30",{"name":5,"class":6},1]