[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100422667":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":36,"locations":46,"responsibleParty":67,"collaborators":10,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":10,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":10,"maxAge":10,"enrollmentInfo":77,"targetDuration":10,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Spontaneous HSIL regression",null,"Patients that have spontaneous regression of HSIL throughout follow-up. Patients in this group will be further classified into 3 subgroups: total resolution (no colposcopic lesion, normal pathology by biopsy and cytology, and negative HPV for the HPV type initially detected); partial resolution (regression of colposcopic lesion, negative cytology and biopsies, but persistence of the initial hrHPV detected); and lesion regression (HSIL no longer detected, but persistent LSIL in either cytology, histology or colposcopy).",[13],"Diagnostic Test: Conservative management with regular follow-up",{"label":15,"type":10,"description":16,"interventionNames":17},"Conization","Women who have cervical conization for any reason during follow-up. Patients in this group will be further classified according to indication criteria: failure to meet criteria for conservative management or persistence of HSIL after 24 months of follow-up.",[18],"Procedure: Conization",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DIAGNOSTIC_TEST","Conservative management with regular follow-up","Women will be followed-up every 4 months, with colposcopy and cytology at each visit.",[9],{"type":26,"name":15,"description":27,"armGroupLabels":28,"otherNames":10},"PROCEDURE","Women with progression of HSIL, HSIL persistence after 24 months of follow-up, or that no longer meet the criteria for surveillance will have conization",[15],[30,33],{"name":31,"affiliation":5,"role":32},"Cristina Vanrell Barbat, MD","STUDY_DIRECTOR",{"name":34,"affiliation":5,"role":35},"Nerea Nerea","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},"Natalia Teixeira, MD, Ph.D.","CONTACT","+34604311873","nteixeira@santpau.cat",{"name":43,"role":39,"phone":44,"phoneExt":10,"email":45},"Nerea Nerea, MD","+34935537041","nluqui@santpau.cat",[47],{"facility":48,"status":49,"city":50,"state":10,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Hospital de la Santa Creu i Sant Pau","RECRUITING","Barcelona","08041","Spain","ES",{"type":55,"coordinates":56},"Point",[57,58],2.15899,41.38879,{"lat":58,"lon":57},[61,64],{"name":62,"role":39,"phone":63,"phoneExt":10,"email":41},"Natalia Teixeira","0034604311873",{"name":65,"role":39,"phone":66,"phoneExt":10,"email":45},"Nerea Luqui Scarcelli","0034616431871",{"type":68,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100422667","conservative-management-of-hsil-in-patients-with-future-pregnancy-aspiration-100422667",false,"NCT04783805","Conservative Management of HSIL in Patients With Future Pregnancy Aspiration","Conservative Management of Patients Diagnosed With High-grade Squamous Intraepithelial Lesions (H-SIL) Who Have Pregnancy Intentions: a Prospective Observational Study","Inclusion Criteria:\n\n* Reproductive age and aspirations of future pregnancies\n* Acceptance of conservative management\n* Commitment to attend scheduled follow-up visits\n* Colposcopy with transformation zone (ZT) type 1 or 2 (fully visible squamous-columnar union) with lesion with grade 2 changes visible in its entirety. No endocervical involvement\n* Colposcopy with grade 2 changes that are not extensive: \\\u003C50% of the cervical surface\n\nExclusion Criteria:\n\n* Pregnancy at first visit or during follow-up.\n* Immunosuppression (either iatrogenic or due to human immunodeficiency virus (HIV))\n* Suspected or diagnosed Atypical Glandular Cells (ACG), In Situ Adenocarcinoma (AIS) or Cervical Cancer (CC)","FEMALE",{"count":78,"type":79},200,"ESTIMATED","OBSERVATIONAL","Conservative management of high-grade squamous intraepithelial lesions (HSILs) seems safe and justified in young women (\\\u003C30 years), but evidence is insufficient on whether it is also advisable for older women.\n\nThis study will be conducted to analyze spontaneous HSIL regression rates in women of reproductive age and establish whether conservative HSIL management could be safely recommended to women of childbearing potential, irrespective of age.\n\nThis is a single-center prospective observational study that will include consecutive women of reproductive age, referred to a tertiary hospital due to HSIL between March 2021 and December 2025, who prefer conservative management rather than immediate cervical conization.\n\nAll patients will be followed-up regularly with colposcopy, cytology, human papillomavirus (HPV) testing and biopsies. In case their lesions progress or HSIL persists after 24 months of follow-up, conization will be indicated. Rates of spontaneous regression or resolution, as well as progression rates, will be assessed. Furthermore, the association between potential predictive factors and HSIL resolution will be analyzed.",[83,84,85],"Cervical Intraepithelial Neoplasia","Squamous Intraepithelial Lesions of the Cervix","Uterine Cervical Dysplasia",[87,88,89],"H-SIL","Conservative management","CIN","2021-03-04",{"date":92,"type":93},"2021-03-05","ACTUAL",{"date":95,"type":93},"2021-03-03",{"date":97,"type":79},"2027-12-31",{"name":5,"class":6},1]