[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cervical-intraepithelial-neoplasia-grade-23\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cervical-intraepithelial-neoplasia-grade-23":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,55,87,119],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":37,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100634904","phase-2-adjuvant-5-fluorouracil-following-thermal-ablation-to-improve-hpv-treatment-outcomes-in-women-with-hiv-in-kenya-100634904",false,"NCT07545746","Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya","Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya : The ASCEND Trial","ASCEND","Inclusion Criteria\n\n* Women aged 25 years or older\n* Known HIV-positive status\n* On antiretroviral therapy (ART) for at least 60 days prior to enrollment\n* Positive HPV screening test screening result\n* Able to provide informed consent in English, Swahili, or Dholuo\n* Agree to use dual contraception during dosing phase if of childbearing potential\n* Planning to remain in study locale for duration of study (48 weeks) Exclusion Criteria\n* Current pregnancy or breastfeeding\n* History of anogenital cancer (cervical, vulvar, or anal)\n* Current use of immunosuppressive medications\n* History of total hysterectomy\n* Known allergy to 5FU\n* Medical comorbidity that would interfere with study participation\n* Unwilling or unable to use contraception during study participation","FEMALE","25 Years",{"count":20,"type":21},140,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This randomized, placebo-controlled trial will evaluate self-administered 5-fluorouracil (5FU) to improve human papillomavirus (HPV) clearance after thermal ablation (TA) in Women With Human Immunodeficiency Virus (HIV) (WWH) in Kenya. The trial will also assess the safety, adherence, and acceptability of 5FU. Starting four weeks after TA, participants will self-administer 5FU cream or matched placebo intravaginally once every other week for 12 applications, with clinic visits at weeks 2, 8, 16, 24, and 48 for evaluation. All participants will be followed up to 48 weeks.\n\nIt is hypothesized that, compared to placebo, 5FU will increase HPV clearance at 24 weeks and that the proposed dosing schedule will be safe, well-tolerated, and acceptable in this population. Together with data from other studies, this trial will provide evidence on the use of self-administered intravaginal 5FU to improve HPV treatment outcomes in WWH in low- and middle-income countries, where the burden of cervical cancer is highest.",[27,28,29,30,31,32,33,34,35,36],"HIV Infections","HPV Infection","Cervix Cancer","CIN2","CIN3","CIN1","CIN","Cervical Intraepithelial Neoplasia Grade 3","Cervical Intraepithelial Neoplasia Grade 1","Cervical Intraepithelial Neoplasia Grade 2\u002F3",[38,39,40,41],"5-fluorouracil (5FU)","thermal ablation (TA)","placebo","intravaginal topical","NOT_YET_RECRUITING","2026-06-01",{"date":45,"type":46},"2026-06-02","ACTUAL",{"date":48,"type":21},"2026-07",{"date":50,"type":21},"2028-03",{"name":52,"class":53},"UNC Lineberger Comprehensive Cancer Center","OTHER",2,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100627921","phase-2-pvx4-for-the-treatment-of-human-papilloma-virus-hpv16-cervical-dysplasia-100627921","NCT07454915","PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia","Inclusion Criteria:\n\n1. Female subjects 18-60 years old with biopsy-confirmed high grade cervical intraepithelial neoplasia (CIN2\u002F3) confirmed by central review.\n2. Patients whose cytobrush samples are HPV16+ by Roche Cobas genotyping test. Co-infections with HPV types other than HPV16 are permissible for study entry\n3. HIV negative\n4. Patients who are able and willing to comply with all study procedures, and with anticipated availability for the planned follow-up period of one year\n5. Patients who are of childbearing potential agree to remain sexually abstinent, use methods of contraception (e.g. oral contraception, barrier methods, spermicide, intrauterine device (IUD)), or have a partner who is sterile (i.e., vasectomy) through 6 months.\n6. Patients must have adequate organ function at the time of enrollment as defined by the following parameters: white blood cell count \\>3,000\u002FmcL; lymphocyte number \\>500\u002FmcL; absolute neutrophil count \\>1,000\u002FmcL; platelets \\>90,000\u002FmcL; hemoglobin \\>9 g\u002FdL; total bilirubin \\\u003C3 X the institutional limit of normal; aspartate aminotransferase (AST \\[SGOT\\]) \u002F alanine aminotransferase (ALT \\[SGPT\\]) \\\u003C3 X the institutional limit of normal; creatinine \\\u003C2.5X the institutional limit of normal.\n\nExclusion Criteria:\n\n1. Patients who are attempting pregnancy within 6 months, pregnant, or breastfeeding.\n2. Patients with immunodeficiency, or treatment with immunosuppressive medications\n3. Administration of any blood product within 3 months of enrollment.\n4. Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for a live vaccine)\n5. Participation in a study with an investigational compound or device within 30 days of signing informed consent.\n6. History of seizures (unless seizure free for 5 years)\n7. Previous cancer history within the past 5 years, except localized skin cancer.\n8. Patients who have had chemotherapy, radiation, biological cancer therapy, or other investigational agents within 28 days prior to the first dose of study drug.\n9. Patients who have had surgery within 28 days, excluding minor procedures (dental work, skin biopsy, etc).\n10. Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing, or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n11. Patients who have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis).\n12. Previous cervical conization or LEEP procedure or previous total hysterectomy due to cervical lesions at enrollment\n13. High-grade intraepithelial lesions (CIN2\u002F3) encompassing more than 180-degree (more than 2 quarters) of cervix\n14. Positive HBV PCR if Hepatitis B surface antigen positive\n15. Positive HCV PCR if anti-HCV positive\n16. Border of high-grade intraepithelial lesions (CIN2\u002F3) could not be completely observed by colposcope and positive for high grade disease by endocervical curettage.\n17. Cervical biopsy and\u002For ECC of adenocarcinoma in situ (AIS)\n18. Pre-biopsy Pap of Atypical Glandular Cells (AGC)\u002FAGC favor neoplasm, squamous cell carcinoma (SCC), or cervical biopsy of CIN2\u002F3 with postmenopausal bleeding\n19. Participant has:\n\n    1. Less than 2 acceptable potential injection sites for IM injection and electroporation considering the left and right medial deltoid, and anterolateral quadriceps muscles. A site for injection and electroporation is not acceptable if there is inadequate muscle mass to support at least a 19 mm\u002F0.75 inch injection depth or a skinfold thickness measurement of ≥50 mm as assessed using the provided caliper. Eligible injection sites must also be free from tattoos, hypertrophic skin patches, keloids or other skin conditions which could interfere with the administration procedure or subsequent assessment of local reactogenicity.\n    2. Note: To ensure adequate muscle mass for administrations, for participants with a weight ≤65 kg, potentially eligible administration sites are confined to the outer aspect of the upper thigh (left or right vastus lateralis muscle) (i.e., the left and right medial deltoid are not eligible administration sites).\n20. Contraindication to intramsucular injections and blood draws.\n21. A metal implant or implantable device within the area of the electroporation injection site at \\> 2 of the eligible injection sites.\n22. A nonremovable electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.\n23. Participant is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.\n24. Vulnerable participants (e.g., incarcerated individuals, individuals under a legal protection measure).","18 Years","60 Years",{"count":64,"type":21},138,[24],"The purpose of this Phase 2 study is to compare the effects of administering the PVX4 combination device biologic product (pBI-4 DNA vaccine via electroporation-mediated intramuscular delivery with the TriGrid™ Delivery System) in patients with biopsy-confirmed, human papilloma virus (HPV) 16-associated high grade cervical intraepithelial neoplasia (CIN2\u002F3) as compared to the administration of placebo.",[36,68],"Human Papilloma Virus Infection Type 16",[70,71,72,73,74,75],"Human papilloma virus","HPV16","HSIL","CIN 2\u002F3","DNA vaccine","Cervical intraepithelial neoplasia","RECRUITING","2026-05-03",{"date":79,"type":46},"2026-05-06",{"date":81,"type":46},"2026-04-01",{"date":83,"type":21},"2028-06",{"name":85,"class":53},"PapiVax Biotech, Inc.",10,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":4},"100537109","phase-1-a-study-in-subjects-with-human-papillomavirus-16-or-18-associated-cervical-intraepithelial-neoplasia-grade-2-or-3-100537109","NCT06273553","A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3","An Open-Label, Phase 1\u002F2 Study to Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of RG002 Injection (an mRNA Therapeutic Vaccine) in Subjects With Human Papillomavirus (HPV) 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3 (CIN2\u002F3)","Inclusion Criteria:\n\n1. Written informed consent in accordance with study site guidelines.\n2. Female 18\\~45 years of age when signing the ICF for Part A, and 18\\~55 years of age when signing the ICF for Part B.\n3. Body mass index (BMI) ≤30 kg\u002Fm2.\n4. Pathological diagnosis of CIN Grade 2 or 3 as confirmed by central pathological reviewers within 12 weeks prior to administration of first study vaccination.\n5. The lesion of CIN Grade 2 or 3 is large enough for histopathologic biopsy at screening and during treatment.\n6. Has a satisfactory colposcopy at screening, i.e., the entire lesion as well as the entire squamocolumnar junction (type 1 or 2 transformation zone) is visualizable by colposcopy;\n7. Confirmed high-risk HPV infection with HPV16+ and \u002F or HPV18+ by a commercially available high-risk DNA assay (e.g., Cobas® HPV test from Roche).\n8. Adequate hematologic, renal, and hepatic function are determined by the Investigator, based upon medical history, physical examination, and laboratory test results at screening:\n\n   1. Bone marrow function: absolute neutrophil count ≥1,500\u002FµL, hemoglobin (HGB) ≥ 9 g\u002FdL, and platelets ≥ 100,000\u002F µL.\n   2. Renal function: creatinine ≤ 1.5 × institutional upper limit of normal (ULN).\n   3. Hepatic function: total bilirubin ≤ 1.5 × ULN, Aspartate aminotransferase (AST) and\u002For alanine transaminase (ALT) ≤ 1.5 × ULN.\n9. Women of child-bearing potential (WOCBP) agree to remain sexually abstinent, use medically effective contraception (i.e., complex contraception, male condom and spermicide, contraceptive patches, barrier methods, spermicide, etc.), from enrollment to 9 months after the last injection or have a partner who is sterile (i.e., vasectomy).\n10. Able and willing to comply with all study procedures.\n\nExclusion Criteria:\n\n1. Cervical adenocarcinoma in situ (AIS), or atypical endometrial or glandular cells, or evidence of invasive cervical carcinoma on cervical biopsy within 12 weeks prior to administration of first study vaccination.\n2. High-grade intraepithelial neoplasia or invasive carcinoma of vulva, vagina or anus.\n3. History of severe allergy to any vaccine or serious hypersensitivity reaction to a known ingredient (e.g., PEG) of RG002 injection judged by the investigator.\n4. Active infection with herpes simplex virus (HSV).\n5. Positive serological test at screening for HIV virus, active syphilis infection, or positive hepatitis B virus surface antigen (HbsAg) and the number of copies of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 500 IU\u002FmL (or 2500 copies, or the lower limit of the positive detection value of the study site) at screening, or HbsAg (-), hepatitis B core antibody (HbcAb) (+) and the number of copies of HBV DNA ≥ 500 IU\u002FmL (or 2500 copies, or the lower limit of the positive detection value of the study site) after treatment of HBV infection, or positive hepatitis C antibody (HCV-Ab) and hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ ULN of the study site.\n6. Subjects with a concurrent condition of fatty liver disease at screening.\n7. Subjects with poorly controlled diabetes (fasting blood glucose ≥ 10mmol\u002FL) after drug treatment at screening.\n8. History of serious cardiovascular and cerebrovascular diseases, including but not limited to serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention; repeated 12-lead ECG with QTcF interval ≥ 470 msec; acute coronary syndrome, congestive cardiac failure, aortic dissection, stroke or other Grade 3 or above cardiovascular and cerebrovascular events within 6 months before the first administration; New York Heart Association (NYHA) cardiac function classification ≥ Grade III or hypertension that cannot be clinically controlled (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg).\n9. Major surgery (except for surgery for diagnostic purposes) within 4 weeks before the first administration or expected to undergo major surgery (except for surgery for diagnostic purposes) during the study period; If major surgery occurred \\> 4 weeks prior to the first administration of the study, individual must have recovered adequately from the toxicity and\u002For complications from the intervention prior to the first administration of the study.\n10. Hereditary hemorrhagic tendency or coagulation dysfunction, or a history of thrombosis or hemorrhagic disease, or requirement of continuous use of anticoagulants.\n11. Female subjects in pregnancy or lactation, or a positive result on a serum human chorionic gonadotropin (HCG) test at screening (Visit 1) or a positive urine pregnancy test pre-vaccination at Visit 2 (and at subsequent vaccination visits).\n12. Currently receiving or has received treatment with systemic steroids in the following dosages prior to administration of the first study vaccination.\n\n    1. Long-term corticosteroids: ≥0.5 mg\u002Fkg\u002Fday of oral prednisolone or equivalent, within 30 days prior to administration of the first study vaccination.\n    2. Sporadic corticosteroids: ≥1 mg\u002Fkg\u002Fday of oral prednisolone or equivalent for 2 or more short courses of \\> 3 days.\n\n    Note: Current or recent use of eye drop or inhaled glucocorticoid therapy is acceptable.\n13. Immunosuppression due to treatment for concurrent disease or medical history: HIV treatment, antirheumatic drugs, organ or bone marrow transplantation or relevant treatment.\n14. Systemic treatment for malignancy within 2 years of enrollment.\n15. Administration of any blood product within 3 months of enrollment.\n16. Administration of any vaccine within 4 weeks of enrollment.\n17. A history of any therapeutic HPV vaccination (commercially approved prophylactic HPV vaccination is acceptable).\n18. Other condition or prior therapy that, in the opinion of the investigator, compromises the subject's welfare or may confound study results.\n19. Tattoos, scars, or active lesions\u002Frashes within 2 cm of the intended site of vaccination (deltoid muscle) or any implantable leads, that may affect the safety observation.\n20. Adverse events that do not recover to grade 1 during the screening period.\n21. Subjects are currently participating or has participated in a study with an investigational drug or device within 30 days of signing informed consent.\n22. Subjects who are judged by the investigator to have a history of other serious systemic diseases, or not suitable for participating in the trial for any other reason (the subject has mental illness, alcohol abuse, drug use or drug abuse that may affect her compliance with the trial or may interfere with the interpretation of the study results).","55 Years",{"count":96,"type":21},39,[98,24],"PHASE1","The purpose of this study is to to evaluate the safety, tolerability, immunogenicity, and efficacy of RG002 Injection in subjects with HPV16\u002F18 associated Cervical Intraepithelial Neoplasia Grade 2 or 3(CIN2\u002F3).",[101,36,102,103],"Human Papillomavirus Associated Intraepithelial Neoplasia","Human Papillomavirus Type 16 Infection","Human Papillomavirus Type 18 Infection",[105,106,107,108],"HPV 16 or 18","mRNA vaccine","CIN 2","CIN 3","2024-02-15",{"date":111,"type":46},"2024-02-22",{"date":113,"type":21},"2024-03",{"date":115,"type":21},"2027-12",{"name":117,"class":118},"RinuaGene Biotechnology Co., Ltd.","INDUSTRY",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":126,"targetDuration":128,"studyType":129,"phases":4,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100470393","predicting-response-in-cervical-intraepithelial-neoplasia-to-topical-imiquimod-treatment-100470393","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",{"count":127,"type":21},410,"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).",[132,36,73,133],"Cervical High Grade Squamous Intraepithelial Lesion","Cervical Intraepithelial Neoplasia",[135,136,137,138,139,140],"Cervical high-grade squamous intraepithelial lesion (cHSIL)","Imiquimod","Tumor immunemicroenvironment","High-risk human papilloma virus (hrHPV)","Cervical intraepithelial neoplasia (CIN)","Biomarker","2023-09-08",{"date":143,"type":46},"2023-09-11",{"date":145,"type":46},"2022-06-01",{"date":147,"type":21},"2026-12",{"name":149,"class":53},"Catharina Ziekenhuis Eindhoven",15]