[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560861":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":40,"centralContacts":45,"locations":55,"responsibleParty":73,"collaborators":76,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":10,"studyType":93,"phases":10,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":58,"whyStopped":10,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Universiteit Antwerpen","OTHER",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Pre-adolescent group",null,"Defined as girls between 9 and 14 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are not yet menstruating (pre-menarche).",[13],"Device: Sampling",{"label":15,"type":10,"description":16,"interventionNames":17},"Ovulatory group","Defined as women between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are not using any hormone- or ovulation-influencing contraceptives that impact hormonal levels during the menstrual cycle.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Ovulation-influencing contraceptive group","Defined as women between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are using ovulation-influencing contraceptives that impact hormonal levels during the menstrual cycle (including oral contraceptives, hormonal ring, contraceptive injection, contraceptive patch, hormonal implant).",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Non-ovulation-influencing contraceptive group","Defined as women between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are using contraceptives that do not affect ovulation (i.e. intrauterine devices).",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Post-menopausal group","Defined as fully vaccinated women between 50 and 70 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and have had no menses for at least one year.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Male group","Defined as fully vaccinated men between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine.",[13],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"DEVICE","Sampling","Collection of first-void urine (i.e. the initial stream of the urine) with the Colli-Pee device (Novosanis, Belgium) (6-21 samples over a period of 36 days).\n\nCollection of blood samples (2 samples, at day 1 and 36 of the study).",[31,23,19,15,27,9],[41],{"name":42,"affiliation":43,"role":44},"Wiebren Tjalma, MD","University Hospital, Antwerp","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":10,"email":50},"Alex Vorsters, Professor","CONTACT","+3232659130","alex.vorsters@uantwerpen.be",{"name":52,"role":48,"phone":53,"phoneExt":10,"email":54},"Margo Bell","+32476014843","margo.bell@uantwerpen.be",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"University of Antwerp","RECRUITING","Edegem","Antwerp","2650","Belgium","BE",{"type":65,"coordinates":66},"Point",[67,68],4.44504,51.15662,{"lat":68,"lon":67},[71,72],{"name":47,"role":48,"phone":49,"phoneExt":10,"email":50},{"name":52,"role":48,"phone":53,"phoneExt":10,"email":54},{"type":44,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Wiebren Tjalma","Professor and Gynecological Oncologist",[77],{"name":43,"class":6},"100560861","normalizing-antibody-detection-in-first-void-urine-100560861",false,"NCT06582654","Normalizing Antibody Detection in First-void Urine","URINORM: Normalizing Antibody Detection in First-void Urine","URINORM","Inclusion Criteria:\n\n* Vaccinated with either the Cervarix, Gardasil or Gardasil9 HPV-vaccine and able to present vaccination booklet or another official document proving this.\n* Able to understand the information brochure and what the study is about.\n* Willing to give informed consent to contact his\u002Fher general practitioner and\u002For gynecologist to access details on their HPV vaccination schedule and, in case a woman within the screening population, cervical cancer screening results (smears, HPV tests, colposcopy, biopsy).\n\nExclusion Criteria:\n\n* Participating in another clinical trial at the same time of participating in this study.\n* Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the six months prior to study enrolment.\n* Pregnant women.\n* Being positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.\n* Having a history or current evidence of any condition or abnormality that might confound the results of the study or is not in the best interest of the individual to participate, in the opinion of the investigator.",true,"ALL","9 Years","70 Years",{"count":91,"type":92},150,"ESTIMATED","OBSERVATIONAL","The aim of this study is to develop robust analytical protocols for the monitoring of vaccine induced immunity against the Human Papillomavirus (HPV) in first-void urine samples and to examine fluctuations of urinary HPV-specific antibodies and potential normalization markers in different cohorts.",[96],"Human Papillomavirus Infection",[98,99,100,101],"Antibodies","Vaccination","Self-sampling","First-void urine","2024-08-30",{"date":104,"type":105},"2024-09-03","ACTUAL",{"date":107,"type":105},"2023-12-07",{"date":109,"type":92},"2026-01-01",{"name":5,"class":6},1]