[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100375669":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":23,"locations":29,"responsibleParty":46,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":10,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Hospital San Carlos, Madrid","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"vaccinated women",null,"* Women older than 18 years who received excisional therapy due to HSIL \u002FCIN injury confirmed histologically.\n* Women who sign informed consent.\n* Patients with negative results in the first post-surgery control.\n* Patients who have received HPV vaccination and provide vaccination card.",[13],"Drug: HPV vaccine",{"label":15,"type":10,"description":16,"interventionNames":10},"non vaccinated woman","* Women older than 18 years who received excisional therapy due to HSIL \u002FCIN injury confirmed histologically.\n* Women who sign informed consent.\n* Patients with negative results in the first post-surgery control.\n* Patients who have NOT received HPV vaccination and provide vaccination card.",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DRUG","HPV vaccine",". Patients diagnosed with HSIL \u002F CIN 2+ who met the inclusion criteria were submitted to cervical conization and subsequently enrolled in the study after signing the informed consent, approved by ethics commission.\n\nWe will take into account the date of administration of the first dose of vaccine. The types of vaccines administered can be: Bivalent vaccine (includes genotypes 16\u002F18), Tetravalent (includeds genotypes 6, 11, 16 and 18) both funded in the region in different years, or not funded (Nonavalent vaccine; includes genotypes: 6, 11, 16, 18, 31, 33, 45, 52 and 58). To define the time of vaccination around the conization date, the administration of the first dose of vaccine will be taken into account.",[9],[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"ANDREA CASAJUANA PÉREZ","CONTACT","0034 913 30 30 01","andreamercedes.casajuana@salud.madrid.org",[30],{"facility":31,"status":32,"city":33,"state":10,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Hospital Clinico San Carlos","RECRUITING","Madrid","28040","Spain","ES",{"type":38,"coordinates":39},"Point",[40,41],-3.70256,40.4165,{"lat":41,"lon":40},[44],{"name":45,"role":26,"phone":27,"phoneExt":10,"email":28},"ANDREA CASAJUANA PEREZ",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","ANDREA CASAJUANA","PLUVIO CORONADO MARTÍN",[51],{"name":52,"class":53},"Merck Sharp & Dohme LLC","INDUSTRY","100375669","retrospective-cohort-study-of-the-effectiveness-of-the-prophylactic-vaccine-against-the-human-papilloma-virus-in-the-prevention-of-recurrence-in-women-who-have-received-an-excisional-therapy-by-hsil--cin-100375669",false,"NCT04171505","Retrospective Cohort Study of the Effectiveness of the Prophylactic Vaccine Against the Human Papilloma Virus in the Prevention of Recurrence in Women Who Have Received an Excisional Therapy by HSIL \u002F CIN.","Retrospective Cohort Study to Analyze Whether Prophylactic Vaccination Against HPV Can Reduce the Risk of Recurrence in Women Who Have Received an Excisional Therapy for HSIL \u002F CIN2-3. Recurrence is Defined as the Detection of Infection by the Same HPV Genotype for at Least 6-12 Months (Persistent Infection), and \u002F or Cytological Alteration and \u002F or Cervical and \u002F or Vaginal Histological Lesion of Any Grade (SIL \u002F CIN \u002F VaIN) in Patients With Negative Cotest in the First Post Control.","VENUS","Inclusion Criteria:\n\n* Women older than 18 years who received excisional therapy due to HSIL \u002FCIN injury confirmed histologically.\n* Women who sign informed consent.\n* Patients with negative results in the first post-surgery control.\n* Patients who have received HPV vaccination and provide vaccination card.\n\nExclusion Criteria:\n\n* Women who do not wish or cannot give their informed consent and \u002F or do not comply with the requirements of the study.\n* Patients treated by an indication other than HSIL\u002FCIN.\n* Patients under immunosuppression conditions.","FEMALE","18 Years","100 Years",{"count":66,"type":67},508,"ESTIMATED","OBSERVATIONAL","A retrospective cohort study of women treated by excisional therapy due to HSIL\u002F CIN at Clínico San Carlos Hospital between 2012-2018. The effectiveness of prophylactic vaccination against HPV in women treated for HPV-related disease will be evaluated. For this purpose, the percentage of cervical lesion recurrence among a group of treated and vaccinated women against HPV between the years 2015-2018 will be compared with a control group of treated and non-vaccinated women against HPV since 2012-2015.\n\nIt will be an essential requirement that the patient provide a vaccination card from their health center where there is proof of their immunization status and date of administration.\n\nInclusion criteria:\n\n* Women older than 18 years who received excisional therapy due to HSIL \u002FCIN injury confirmed histologically.\n* Women who sign informed consent.\n* Patients with negative results in the first post-surgery control.\n* Patients who have received HPV vaccination and provide vaccination card.\n\nExclusion criteria:\n\n* Women who do not wish or cannot give their informed consent and \u002F or do not comply with the requirements of the study.\n* Patients treated by an indication other than HSIL\u002FCIN.\n* Patients under immunosuppression conditions.",[71,72,73,74],"Cervix, Dysplasia","HPV Infection","HPV Vaccine","Cervix Lesion","UNKNOWN","2019-11-19",{"date":78,"type":79},"2019-11-21","ACTUAL",{"date":81,"type":79},"2019-11-04",{"date":83,"type":67},"2020-12",{"name":5,"class":6},1]