[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475362":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":75,"collaborators":77,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":12,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":43,"whyStopped":12,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control arm: no compressive garments","NO_INTERVENTION","Patients detected with early stage LLL (0-1 ISL stadia) start with education and preventive measures.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Interventional arm: start of CC2 compressive garments","EXPERIMENTAL","Patients in the experimental arm and detected with early stage LLL (0-1 ISL stadia) start with CC2 compressive garments in addition to education and preventive measures.",[18],"Device: Compressive garments class II",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Compressive garments class II","Daily wearing of compressive garments, especially during prolonged standing upright or strenuous activities.",[14],[26],"Flat knit Medi Cosy compression class II stockings and\u002For bermuda",[28],{"name":29,"affiliation":5,"role":30},"Chris Monten, MD, PhD","PRINCIPAL_INVESTIGATOR",[32,36],{"name":29,"role":33,"phone":34,"phoneExt":12,"email":35},"CONTACT","093320749","chris.monten@uzgent.be",{"name":37,"role":33,"phone":38,"phoneExt":12,"email":39},"Caren Randon, MD, PhD","093326252","caren.randon@uzgent.be",[41,61],{"facility":42,"status":43,"city":44,"state":12,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Ghent University Hospital, Dept. Radiotherapy-Oncology","RECRUITING","Ghent","9000","Belgium","BE",{"type":49,"coordinates":50},"Point",[51,52],3.71667,51.05,{"lat":52,"lon":51},[55,58],{"name":56,"role":33,"phone":57,"phoneExt":12,"email":35},"Chris Monten, M.D., PhD","+32 9 332 0749",{"name":59,"role":33,"phone":60,"phoneExt":12,"email":39},"Caren Randon, M.D., PhD","+32 9 332 6252",{"facility":62,"status":43,"city":63,"state":12,"zip":64,"country":46,"countryCode":47,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"University Hospital, Louvain","Leuven","3000",{"type":49,"coordinates":66},[67,68],4.70093,50.87959,{"lat":68,"lon":67},[71],{"name":72,"role":33,"phone":73,"phoneExt":12,"email":74},"Nele Devoogdt, PhD","016342515","nele.devoogdt@uzleuven.be",{"type":76,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[78,80],{"name":62,"class":79},"UNKNOWN",{"name":81,"class":6},"Kom Op Tegen Kanker","100475362","lymphedema-after-gyneco-oncologic-treatment-100475362",false,"NCT05469945","Lymphedema After Gyneco-oncologic Treatment","Lower Limb Lymphedema After Gyneco-oncologic Therapy: Can we Prevent Irreversible Lymphedema?","Gynolymph","Inclusion Criteria:\n\n* Signed informed consent (ICF)\n* Female patient, recently diagnosed with gynaecologic cancer (cervix, endometrium, vulva, vagina, ovaries…) and candidate for curative treatment\n* Age ≥ 18 years\n* Understanding of the Dutch language\n* Able to understand the informed consent and willing to comply with the protocol, including use of diary or app and timely completion of requested questionnaires.\n\nExclusion Criteria:\n\n* History of treatment for gynaecologic cancer\n* Concurrent second primary tumor(s)\n* Pregnancy or pregnancy planned within 2 years\n* Known metastasized cancer at the time of inclusion (D0)\n* Severe injury, surgery or deformation of the legs or groins in the past\n* Vascular malformation of the leg or untreated venous insufficiency with oedema (CEAP C4 or more)\n* Mental or psychological problems, inability to comply to the study protocol\n* First treatment administered \\> 2 weeks before\n* Clinical signs and symptoms of lymphedema present (ISL stage 0 or higher) at the moment of intake","FEMALE","18 Years","99 Years",{"count":94,"type":95},218,"ESTIMATED","INTERVENTIONAL",[98],"NA","Trial developed to inventory the incidence of early and advanced stage lower limb lymphedema in patients diagnosed with and treated for gynaecologic cancer.\n\nFour hundred patients with diagnosis stage 1-3 gynaecologic cancer will be included in an observational cohort between diagnosis until maximum 2 weeks after start of the first treatment. They will be followed for occurrence of lower limb lymphedema up till 2 years after their last treatment.\n\nData on signs and symptoms, quality of life, time investment and financial expenses will be collected, to provide information on the incidence and risk factors for lower limb lymphedema, and on its impact on patients, regarding quality of life, sexual well-being and time- and financial investment.\n\nPatients developing early stage LLL enter an interventional sub-cohort, in which the effect of class II compressive garments on preventing evolution towards advanced stage LLL will be evaluated.",[101,102],"Lymphedema","Genital Neoplasm",[104,105,106,107,108,109],"Lymphedema of the lower limb","Gynaecologic cancer","Sexual well-being","Quality of Life","Cost-investment","Time-investment","2024-06-17",{"date":112,"type":113},"2024-06-20","ACTUAL",{"date":115,"type":113},"2022-06-22",{"date":117,"type":95},"2028-06-30",{"name":5,"class":6},2]