[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461149":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":79,"collaborators":83,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":10,"eligibilityCriteria":99,"healthyVolunteers":96,"sex":100,"minAge":101,"maxAge":10,"enrollmentInfo":102,"targetDuration":105,"studyType":106,"phases":10,"briefSummary":107,"conditions":108,"keywords":116,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Bispebjerg Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Male organ transplant recipients",null,"300 men with a solid organ transplant (heart, lung, liver, kidney or pancreas)",[13],"Other: No intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Female organ transplant recipients","600 women with a solid organ transplant (heart, lung, liver, kidney or pancreas)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Female immunocompetent controls","600 immunocompetent women without organ transplant or other immunosuppressive conditions\u002Ftreatments",[13],[23],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"No intervention","The study is an observational study without intervention.",[19,15,9],[28],{"name":29,"affiliation":5,"role":30},"Merete Hædersdal, DMSc, MD","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Lene Rask","CONTACT","+45 23359940","lene.rask.01@regionh.dk",[38,51,65],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":10,"geoPoint":10,"contacts":46},"Department of Dermatology, Bispebjerg Hospital","RECRUITING","Copenhagen NV","Capital Region","2400","Denmark","DK",[47,49],{"name":29,"role":34,"phone":10,"phoneExt":10,"email":48},"mhaedersdal@dadlnet.dk",{"name":50,"role":34,"phone":10,"phoneExt":10,"email":36},"Lene Rask, PhD",{"facility":52,"status":40,"city":53,"state":42,"zip":54,"country":44,"countryCode":45,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Department of Dermatology and Allergy, Herlev og Gentofte Hospital","Hellerup","2900",{"type":56,"coordinates":57},"Point",[58,59],12.57093,55.73204,{"lat":59,"lon":58},[62],{"name":63,"role":34,"phone":10,"phoneExt":10,"email":64},"Claus Zachariae, DMSc, MD","claus.zachariae@regionh.dk",{"facility":66,"status":40,"city":67,"state":68,"zip":69,"country":44,"countryCode":45,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Department of Dermatology, Zealand University Hospital","Roskilde","Region Sjælland","4000",{"type":56,"coordinates":71},[72,73],12.08035,55.64152,{"lat":73,"lon":72},[76],{"name":77,"role":34,"phone":10,"phoneExt":10,"email":78},"Gabrielle Vinding, Ass. Professor, PhD, MD","gbj@regionsjaelland.dk",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Merete Haedersdal","Principal investigator",[84,86,88,90,92],{"name":85,"class":6},"Danish Cancer Society",{"name":87,"class":6},"Zealand University Hospital",{"name":89,"class":6},"Vejle Hospital",{"name":91,"class":6},"Herlev and Gentofte Hospital",{"name":93,"class":6},"Rigshospitalet, Denmark","100461149","the-organ-transplant-recipient-hpv-and-skin-cancer-study-100461149",false,"NCT05284877","The Organ Transplant Recipient HPV and Skin Cancer Study","Inclusion Criteria for OTRs:\n\n* Patients aged ≥18 years\n* Solid organ transplantation recipients, i.e. kidney-, liver-, lung-, and heart transplant recipients\n* Stable immunosuppressive treatment for ≥3 months\n* No signs of acute graft rejection\n* Patients who reside in Denmark\n* Informed written consent obtained\n\nExclusion Criteria for OTRs:\n\n* Patients with concomitant bone marrow transplantation\n* Full hysterectomy\n\nInclusion Criteria for Control group:\n\n* Able patients aged ≥18 years\n* No known immunosuppressive therapy or -condition\n* Patients who reside in Denmark\n* Informed written consent obtained\n\nExclusion Criteria for Control group:\n\n\\- Full hysterectomy","ALL","18 Years",{"count":103,"type":104},1500,"ESTIMATED","12 Months","OBSERVATIONAL","Solid organ transplant recipients (OTRs) receive lifelong immunosuppressive therapy, which puts them at increased risk of cutaneous and mucosal cancers. In particular, OTRs have increased risk of skin cancer and cancers caused by human papillomavirus (HPV), including cervical cancer and oropharyngeal cancer. There is currently limited knowledge on risk factors for HPV infection and skin cancer in OTRs, and limited knowledge on the natural history of HPV infection and cervical neoplasia in OTRs compared with immunocompetent controls. With a continuously increasing number of OTRs, there is a growing need to improve our understanding of the long-term reactions to immunosuppression.\n\nThe overall aim of this study is to investigate long term effects of immunosuppression on cutaneous and mucosal epithelium in Danish OTRs, including the risk of skin dysplasia and skin cancer, cervical and oral HPV infection and HPV-related dysplasia and cancer in OTRs.\n\nThis study will be designed as a prospective observational cohort study based on clinical data and data from nationwide Danish registries. A total of 600 female OTRs, 300 male OTRs and 600 female controls will be included from Danish dermatology departments.\n\nThe study aims to provide knowledge relevant for improving prevention of skin- and HPV-related cancers in OTRs, including personalized screening recommendations according to individual patient risk.",[109,110,111,112,113,114,115],"Solid Organ Transplant Recipient","Skin Cancer","Skin Dysplasia","HPV Infection","Cervical Intraepithelial Neoplasia","Cervical Cancer","HPV-Related Malignancy",[117,118,119,120,121,122,123],"Organ transplant recipient","Skin cancer","Skin dysplasia","Human papillomavirus","HPV-related dysplasia","HPV-related cancer","HPV","2025-03-27",{"date":126,"type":127},"2025-04-01","ACTUAL",{"date":129,"type":127},"2022-03-10",{"date":131,"type":104},"2043-03",{"name":81,"class":6},3]