[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543449":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":24,"centralContacts":24,"locations":39,"responsibleParty":58,"collaborators":60,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":24,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":24,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":24,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Barretos Cancer Hospital","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Imiquimod treatment plus Loop Electrosurgical Excision Procedure","EXPERIMENTAL","36 patients diagnosed with CIN 3 who will be undergone 16 applications of 5g imiquimod twice a week and then Loop Electrosurgical Excision Procedure will procedure (60 days). Pathological analysis will evaluate the lesion histologically after immunomodulatory treatment. The individual's immunological response will also be evaluated during applications and after surgical intervention.",[13,14],"Drug: Imiquimod","Procedure: Loop Electrosurgical Excision Procedure",{"label":16,"type":17,"description":18,"interventionNames":19},"Loop Electrosurgical Excision Procedure","ACTIVE_COMPARATOR","30 patients diagnosed with CIN 3 who will be undergone Loop Electrosurgical Excision Procedure (60 days). Pathological analysis will evaluate the lesion histologically after treatment (LEEP). The individual's immunological response will also be evaluated after surgical intervention.",[14],{"label":21,"type":22,"description":23,"interventionNames":24},"healthy population","NO_INTERVENTION","Immunological markers will be evaluated in a healthy population that had negative screening tests for cervical lesions to compare to the population in the injury and intervention groups.",null,[26,33],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Imiquimod","Experimental group will be treated with 16 applications of imiquimod and subsequently LEEP.",[9],[32],"IXIUM",{"type":34,"name":16,"description":35,"armGroupLabels":36,"otherNames":37},"PROCEDURE","Active comparator group will be treated with LEEP.",[9,16],[38],"LEEP",[40],{"facility":5,"status":41,"city":42,"state":24,"zip":24,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Barretos","Brazil","BR",{"type":46,"coordinates":47},"Point",[48,49],-48.56778,-20.55722,{"lat":49,"lon":48},[52],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Ricardo Reis, PhD","CONTACT","+551733216600","7308","drricardoreis@gmail.com",{"type":59,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[61,64,67],{"name":62,"class":63},"Fundação de Amparo à Pesquisa do Estado de São Paulo","OTHER_GOV",{"name":65,"class":66},"Farmoquimica S.A.","INDUSTRY",{"name":68,"class":6},"Hospital de Cancer de Barretos - Fundacao Pio XII","100543449","phase-4-clinical-outcome-and-biomarkers-for-predicting-immunological-response-in-patients-treated-with-imiquimod-100543449",false,"NCT06356012","Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated with Imiquimod","Immunophenotyping, Microbiome, Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients with High-grade Cervical Intraepithelial Lesions Treated with Imiquimod","Inclusion Criteria:\n\n* Patients between 25 and 45 years of age (reproductive age);\n* High-risk HPV carriers;\n* Residents less than 300 km from the city of Barretos-São Paulo;\n* With a histological diagnosis of high-grade cervical squamous intraepithelial lesion (CIN 3), obtained through colposcopy-guided biopsy performed at the Barretos Cancer Hospital (HCB);\n* Acceptance of the Informed Consent Form.\n\nExclusion Criteria:\n\n* Suspicion of invasive squamous cell carcinoma or Adenocarcinoma (in situ or invasive) by colposcopy and\u002For cytology;\n* Pregnant or breastfeeding;\n* Immunodeficiency condition;\n* Previous treatment for high-grade cervical squamous intraepithelial lesion;\n* Who have been immunized for HPV;\n* Have used antibiotics in the last 30 days",true,"FEMALE","25 Years","45 Years",{"count":81,"type":82},96,"ESTIMATED","INTERVENTIONAL",[85],"PHASE4","The goal of this clinical trial is to identify the immunophenotypic profile of the local immune response, the cervicovaginal microenvironment and the microbiological profile of women with CIN 3 treated with imiquimod. Participants will be divided in 3 groups: CIN 3 who will use 16 doses of imiquimod in the uterine cervix, applied twice a week and will be treated with LEEP procedure; 2) patients with CIN 3 who will undergo standard treatment with LEEP procedure; 3) patients with negative cytology and HPV (human papillomavirus) test. Blood and cervicovaginal lavage collections will be performed at different times, for comparisons between cellular response profiles to imiquimod during treatment and baseline levels in healthy patients.",[88,89,90],"HSIL, High-Grade Squamous Intraepithelial Lesions","Vaginal Microbiome","Biomarkers","2025-02-03",{"date":93,"type":94},"2025-02-05","ACTUAL",{"date":96,"type":94},"2024-04-02",{"date":98,"type":82},"2028-12-31",{"name":5,"class":6},1]