[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100470393":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":46,"centralContacts":50,"locations":56,"responsibleParty":222,"collaborators":225,"id":239,"slug":240,"hasResults":241,"nctId":242,"briefTitle":243,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":241,"sex":246,"minAge":247,"maxAge":10,"enrollmentInfo":248,"targetDuration":251,"studyType":252,"phases":10,"briefSummary":253,"conditions":254,"keywords":259,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":274},{"fullName":5,"class":6},"Catharina Ziekenhuis Eindhoven","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Primary cHSIL",null,"Women with a first diagnosis of cHSIL (e.g. CIN 2 or CIN 3) who prefer treatment with imiquimod.",[13,14],"Drug: Imiquimod","Diagnostic Test: 3x vaginal swab for microbiome analysis",{"label":16,"type":10,"description":17,"interventionNames":18},"Recurrent\u002Fresidual cHSIL (rrcHSIL)","Women who were treated for cHSIL before, but who have a residual or recurrent lesion and prefer treatment with imiquimod.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"CIN 2 observational group","Women with primary CIN 2 who prefer expectant management to await the potential of spontaneous regression.",[23,24],"Other: Expectative management","Diagnostic Test: 2x vaginal swab for microbiome analysis",[26,33,38,42],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Imiquimod","Imiquimod 5% will be administered in the evening by either a vaginal applicator or administered on a vaginal tampon for three times a week during 16 weeks. Treatment efficacy will be evaluated after 20 weeks, by colposcopy with diagnostic biopsies, and at 6 months after completion of imiquimod therapy with cytology and if indicated histology.",[9,16],[32],"Aldara",{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"DIAGNOSTIC_TEST","3x vaginal swab for microbiome analysis","A vaginal swab will be taken from all patients at inclusion (before start of imiquimod), at colposcopy 20 weeks after start of imiquimod and at 6 months after completion of imiquimod treatment during follow-up appointment.",[9,16],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":10},"Expectative management","Expectative management of CIN 2 when preferred by the patient. Follow-up 6 months after baseline colposcopy with cytology and if indicated histology.",[20],{"type":34,"name":43,"description":44,"armGroupLabels":45,"otherNames":10},"2x vaginal swab for microbiome analysis","A vaginal swab will be taken from all patients at inclusion and at 6 months after inclusion during follow-up appointment.",[20],[47],{"name":48,"affiliation":5,"role":49},"Edith Van Esch, MD, PhD","PRINCIPAL_INVESTIGATOR",[51],{"name":52,"role":53,"phone":54,"phoneExt":10,"email":55},"Caroline Muntinga, MD","CONTACT","040 - 239 93 00","predict-topic@catharinaziekenhuis.nl",[57,72,83,92,103,114,126,137,148,159,167,178,189,200,211],{"facility":58,"status":59,"city":60,"state":10,"zip":10,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Amphia","RECRUITING","Breda","Netherlands","NL",{"type":64,"coordinates":65},"Point",[66,67],4.77596,51.58656,{"lat":67,"lon":66},[70],{"name":71,"role":53,"phone":10,"phoneExt":10,"email":10},"Dineke Smedts, MD, PhD",{"facility":73,"status":59,"city":74,"state":10,"zip":10,"country":61,"countryCode":62,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Albert Schweitzer Ziekenhuis","Dordrecht",{"type":64,"coordinates":76},[77,78],4.67361,51.81,{"lat":78,"lon":77},[81],{"name":82,"role":53,"phone":10,"phoneExt":10,"email":10},"Gatske Nieuwenhuyzen, MD, PhD",{"facility":5,"status":59,"city":84,"state":10,"zip":10,"country":61,"countryCode":62,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Eindhoven",{"type":64,"coordinates":86},[87,88],5.47778,51.44083,{"lat":88,"lon":87},[91],{"name":52,"role":53,"phone":10,"phoneExt":10,"email":55},{"facility":93,"status":59,"city":94,"state":10,"zip":10,"country":61,"countryCode":62,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Tergooi MC","Hilversum",{"type":64,"coordinates":96},[97,98],5.17639,52.22333,{"lat":98,"lon":97},[101],{"name":102,"role":53,"phone":10,"phoneExt":10,"email":10},"Hélène van Meir, MD, PhD",{"facility":104,"status":59,"city":105,"state":10,"zip":10,"country":61,"countryCode":62,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Medisch Centrum Leeuwarden","Leeuwarden",{"type":64,"coordinates":107},[108,109],5.80973,53.20271,{"lat":109,"lon":108},[112],{"name":113,"role":53,"phone":10,"phoneExt":10,"email":10},"Marjan Keizer, MD",{"facility":115,"status":116,"city":117,"state":10,"zip":10,"country":61,"countryCode":62,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Leiden Universitair Medisch Centrum","NOT_YET_RECRUITING","Leiden",{"type":64,"coordinates":119},[120,121],4.49306,52.15833,{"lat":121,"lon":120},[124],{"name":125,"role":53,"phone":10,"phoneExt":10,"email":10},"Mariëtte van Poelgeest, MD, PhD",{"facility":127,"status":59,"city":128,"state":10,"zip":10,"country":61,"countryCode":62,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Maastricht Universitair Medisch Centrum","Maastricht",{"type":64,"coordinates":130},[131,132],5.68889,50.84833,{"lat":132,"lon":131},[135],{"name":136,"role":53,"phone":10,"phoneExt":10,"email":10},"Peggy de Vos van Steenwijk, MD, PhD",{"facility":138,"status":59,"city":139,"state":10,"zip":10,"country":61,"countryCode":62,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Radboudumc","Nijmegen",{"type":64,"coordinates":141},[142,143],5.85278,51.8425,{"lat":143,"lon":142},[146],{"name":147,"role":53,"phone":10,"phoneExt":10,"email":10},"Petra Zusterzeel, MD, PhD",{"facility":149,"status":59,"city":150,"state":10,"zip":10,"country":61,"countryCode":62,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Erasmus Medisch Centrum","Rotterdam",{"type":64,"coordinates":152},[153,154],4.47917,51.9225,{"lat":154,"lon":153},[157],{"name":158,"role":53,"phone":10,"phoneExt":10,"email":10},"Heleen van Beekhuizen, MD, PhD",{"facility":160,"status":59,"city":150,"state":10,"zip":10,"country":61,"countryCode":62,"cosmosGeoPoint":161,"geoPoint":163,"contacts":164},"Franciscus Gasthuis & Vlietland",{"type":64,"coordinates":162},[153,154],{"lat":154,"lon":153},[165],{"name":166,"role":53,"phone":10,"phoneExt":10,"email":10},"Meike van de Sande, MD",{"facility":168,"status":59,"city":169,"state":10,"zip":10,"country":61,"countryCode":62,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"HagaZiekenhuis","The Hague",{"type":64,"coordinates":171},[172,173],4.29861,52.07667,{"lat":173,"lon":172},[176],{"name":177,"role":53,"phone":10,"phoneExt":10,"email":10},"Kevin Voogdt, MD, PhD",{"facility":179,"status":59,"city":180,"state":10,"zip":10,"country":61,"countryCode":62,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Diakonessenhuis","Utrecht",{"type":64,"coordinates":182},[183,184],5.12222,52.09083,{"lat":184,"lon":183},[187],{"name":188,"role":53,"phone":10,"phoneExt":10,"email":10},"Jacqueline Louwers, MD, PhD",{"facility":190,"status":59,"city":191,"state":10,"zip":10,"country":61,"countryCode":62,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Máxima MC","Veldhoven",{"type":64,"coordinates":193},[194,195],5.40278,51.41833,{"lat":195,"lon":194},[198],{"name":199,"role":53,"phone":10,"phoneExt":10,"email":10},"Viola Verhoef, MD, PhD",{"facility":201,"status":59,"city":202,"state":10,"zip":10,"country":61,"countryCode":62,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"VieCuri Medisch Centrum","Venlo",{"type":64,"coordinates":204},[205,206],6.16806,51.37,{"lat":206,"lon":205},[209],{"name":210,"role":53,"phone":10,"phoneExt":10,"email":10},"Rafli van der Laar, MD, PhD",{"facility":212,"status":59,"city":213,"state":10,"zip":10,"country":61,"countryCode":62,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Isala","Zwolle",{"type":64,"coordinates":215},[216,217],6.09444,52.5125,{"lat":217,"lon":216},[220],{"name":221,"role":53,"phone":10,"phoneExt":10,"email":10},"Arnold-Jan Krüse, MD, PhD",{"type":49,"investigatorFullName":223,"investigatorTitle":224,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Edith van Esch","Principal Investigator, gynaecologist",[226,228,231,233,235,237],{"name":227,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development",{"name":229,"class":230},"Stichting Olijf: Dutch patient association for women with gynaecological cancer","UNKNOWN",{"name":232,"class":230},"Leids Universitair Medisch Centrum: Department of Medical Oncology and Department of Pathology",{"name":234,"class":230},"Maastricht Universitair Medisch Centrum: Department of Gynaecology and Department of Pathology",{"name":236,"class":230},"Erasmus Medisch Centrum: Department of Gynaecology",{"name":238,"class":230},"Radboud Medisch Centrum: Department of Gynaecology","100470393","predicting-response-in-cervical-intraepithelial-neoplasia-to-topical-imiquimod-treatment-100470393",false,"NCT05405270","Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment","PRedICT-TOPIC","Inclusion Criteria:\n\n* Primary cHSIL lesions (e.g. CIN3 or CIN 2), histologically confirmed by diagnostic biopsy Nota bene: In case of CIN 2, expectative management must be discussed according to the Dutch national guideline with the patient, if the patient prefers imiquimod therapy the patient can be treated with imiquimod and enrolled in the study, if the patient prefers expectative management they can be enrolled in the observational CIN 2 group.\n* Recurrent or residual cHSIL lesions after initial LLETZ treatment (e.g. CIN2 or CIN3), histologically confirmed by diagnostic biopsy\n* Age of 18 years or older\n\nExclusion Criteria:\n\n* Concomitant diagnoses of VAIN (vaginal intraepithelial neoplasia e.g. vaginal HSIL)\n* PAP (Papanicolaou) 4 cytology as indication for the baseline colposcopy at study entrance\n* Adenocarcinoma in situ (AIS) diagnosis\n* Previous imiquimod therapy for cHSIL\n* Previous cervical malignancy\n* Current malignant disease\n* Immunodeficiency (including HIV\u002FAIDS and immunosuppressive medication)\n* Pregnancy\n* Legal incapability\n* Insufficient knowledge of the Dutch language","FEMALE","18 Years",{"count":249,"type":250},410,"ESTIMATED","2 Years","OBSERVATIONAL","Imiquimod is a good non-invasive treatment option for women with cervical high-grade squamous intraepithelial neoplasia (cHSIL), especially those with a possible (future) pregnancy wish. Complete response to imiquimod occurs in 55-73% of patients, however side-effects of imiquimod are common and can be extensive. Therefore, biomarkers which can predict response to imiquimod therapy are warranted, to increase therapy efficacy and to avoid side effects in patients who will not respond.\n\nThis prospective, multi-center cohort study aims to validate the potential of immune related biomarkers to predict the clinical response of patients with primary cHSIL to imiquimod, aims to explore the value of these immune biomarkers in recurrent\u002Fresidual cHSIL to predict treatment responses for imiquimod and aims to explore their potential in spontaneous regression of cHSIL (CIN2).",[255,256,257,258],"Cervical High Grade Squamous Intraepithelial Lesion","Cervical Intraepithelial Neoplasia Grade 2\u002F3","CIN 2\u002F3","Cervical Intraepithelial Neoplasia",[260,28,261,262,263,264],"Cervical high-grade squamous intraepithelial lesion (cHSIL)","Tumor immunemicroenvironment","High-risk human papilloma virus (hrHPV)","Cervical intraepithelial neoplasia (CIN)","Biomarker","2023-09-08",{"date":267,"type":268},"2023-09-11","ACTUAL",{"date":270,"type":268},"2022-06-01",{"date":272,"type":250},"2026-12",{"name":5,"class":6},15]