[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100350840":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":43,"responsibleParty":48,"collaborators":43,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":43,"enrollmentInfo":62,"targetDuration":43,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":75,"whyStopped":43,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":43},{"fullName":5,"class":6},"Azienda USL Toscana Nord Ovest","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Gardasil-9","EXPERIMENTAL","Intramuscular Gardasil-9 vaccination at 0, 2 and 6 months.",[13],"Biological: Gardasil-9",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo injection at 0, 2 and 6 months",[19],"Drug: Placebo",[21,28],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","administration by intramuscular injection of the 9-valent HPV vaccine according to a 3-dose vaccination schedule (0, 2, 6 months).",[9],[26,27],"9-valent HPV vaccine","Vaccine against HPV-6, 11, 16, 18, 31, 33, 45, 52, 58",{"type":29,"name":15,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","administration by intramuscular injection of the placebo according to vaccination schedule of the 9-valent HPV vaccine (0, 2, 6 months)",[15],[33],"Sterile Water for Injection Ph. Eur.",[35],{"name":36,"affiliation":37,"role":38},"Alessandro Ghelardi, MD","Az. USL Toscana Nord Ovest","PRINCIPAL_INVESTIGATOR",[40,45],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","+39 0585 6571",null,"alessandro.ghelardi@uslnordovest.toscana.it",{"name":46,"role":41,"phone":42,"phoneExt":43,"email":47},"Paola Bay, MD","paola.bay@uslnordovest.toscana.it",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Alessandro Ghelardi","Principal Investigator, Department of Obstetrics and Gynaecology Azienda USL Toscana Nord Ovest, Presidio Ospedaliero delle Apuane (MS)- Italy","100350840","phase-3-impact-on-disease-relapse-of-hpv-vaccination-in-women-treated-with-leep-for-cervical-intraepithelial-neoplasia-hope9-100350840",false,"NCT03848039","Impact on Disease Relapse of HPV Vaccination in Women Treated With LEEP for Cervical Intraepithelial Neoplasia. HOPE9","A Randomised, Double-Blind, Placebo-Controlled, Phase III Study to Investigate the Efficacy of Presurgical 9-valent HPV Vaccination in Women Treated With LEEP for CIN 2+ and Initially Invasive Cervical Cancer.","HOPE9","Inclusion Criteria:\n\n1. Patients aged ≥ 18 and ecog performance status ≤ 1\n2. Patients with a diagnosis of high-grade cervical intraepithelial neoplasia or initially invasive cervical cancer (histological results ≥ CIN2 + and ≤ Ia1 according to the FIGO staging of cervical cancer)\n3. No fever at the time of vaccination\n4. No previous HPV vaccination\n5. Ability to understand and write Italian\n6. Signed informed and privacy consent\n\nExclusion Criteria:\n\n1. Patients enrolled in other clinical studies\n2. History of allergic reaction or serious adverse events to previous vaccinations\n3. Positive pregnancy test at the time of vaccination\n4. Patient in treatment with immunosuppressive therapy\n5. Subjects who received immunoglobulins or blood products in 3 months prior to vaccination.\n6. Thrombocytopenia or any other clotting disorder that may lead to bleeding as a result of intramuscular administration\n7. Clinical criteria contraindicating the surgical act of conization\n8. ECOG performance status ≥2","FEMALE","18 Years",{"count":63,"type":64},1220,"ESTIMATED","INTERVENTIONAL",[67],"PHASE3","This study evaluates the impact on disease relapse of presurgical 9-valent HPV vaccination versus placebo vaccination in women treated with LEEP (loop electrosurgical excision procedure) for CIN2+ (high grade cervical intraepithelial neoplasia) and initially invasive cervical cancer.",[70],"Cervical Intraepithelial Neoplasia",[72,73,74],"Cervical Cancer","cervical intraepithelial neoplasia","Papillomavirus Vaccines","NOT_YET_RECRUITING","2020-11-04",{"date":78,"type":79},"2020-11-05","ACTUAL",{"date":81,"type":64},"2020-12",{"date":83,"type":64},"2028-05",{"name":50,"class":6}]