[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cervical-intraepithelial-neoplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cervical-intraepithelial-neoplasia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,54,87,116,140,182,216,242,276,308,337,358,384,407,430,453,474,504,532,557],{"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":29,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":4},"100643918","phase-2-hexaminolevulinate-photodynamic-therapy-hal-pdt-versus-surgery-for-high-grade-squamous-intraepithelial-lesions-hsil-100643918",false,"NCT07669363","Hexaminolevulinate Photodynamic Therapy (HAL-PDT) Versus Surgery for High-grade Squamous Intraepithelial Lesions (HSIL)","A Prospective, Open-label, Randomized, Controlled, Non-inferiority Phase II Study Comparing Hexaminolevulinate Photodynamic Therapy (HAL-PDT) Treatment Versus Surgical Treatment in Subjects With High-grade Squamous Intraepithelial Lesions (HSIL)","Aurora","Inclusion Criteria:\n\n* Voluntarily participate in this clinical study, fully understand the study content, procedures, and potential adverse reactions, and be able to sign the written informed consent form.\n* Able to complete the study in accordance with the study protocol.\n* Subject age ≥18 years.\n* Presence of High-Grade Squamous Intraepithelial Lesion (HSIL) (CIN2 P16 positive\u002FCIN3), specifically: HSIL with histopathological diagnosis of grade II\u002FIII (CIN2 P16 positive\u002FCIN3) within 3 months prior to the first treatment.\n* Adequate colposcopy, including: (a) Complete visibility of the cervical transformation zone, including the squamocolumnar junction; (b) Complete visibility of lesion margins.\n* The investigator determines that non-surgical treatment is acceptable for the participant.\n* The investigator determines that the cervical size is suitable for placement of the HAL-PDT device.\n* Meets the following conditions: Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result prior to the start of treatment. No plan for pregnancy during the study period; no sexual activity or use of effective and reliable contraception from the end of the last menstrual period to the start of the study, and agreement to use condoms for barrier contraception during the study period. WOCBP is defined as a female who has experienced menarche, has not undergone hysterectomy or bilateral oophorectomy, and has not reached natural menopause (i.e., no menstruation at all for the past 24 consecutive months).\n\nExclusion Criteria:\n\n* Cervical adenocarcinoma in situ or other glandular lesions, invasive cervical cancer, or suspected malignant lesions.\n* CIN2 with P16 negative.\n* Lesions extending to the vaginal wall, cervical canal, or vaginal fornix, or lesions located on the vulva.\n* Prior physical or surgical treatment to the cervix resulting in incomplete cervical structure (e.g., cold knife conization), or receipt of physical or surgical therapy for CIN2 or CIN3 after the current histopathological diagnosis.\n* The first study treatment day falls within 7 half-lives of the last antiviral medication.\n* Severe pelvic inflammatory disease, severe cervicitis, or other severe gynecological infectious diseases found on colposcopic or clinical examination.\n* Investigator judges that vaginal bleeding during treatment may affect treatment outcomes.\n* Receipt of any inactivated vaccine within 2 weeks prior to the first treatment, or any live vaccine within 4 weeks prior to the first treatment.\n* Previous severe cardiovascular, cerebrovascular, neurological, psychiatric, endocrine, or hematopoietic disease that has not been cured; known severely compromised immune function, or need for long-term use of corticosteroids or immunosuppressants; history of malignancy within 5 years.\n* History of clinically significant immunosuppression or confirmed autoimmune disease; or primary immunodeficiency.\n* Known or newly identified active sexually transmitted diseases (STDs), including but not limited to HIV, syphilis, genital herpes, unless adequately treated and tested negative before study treatment.\n* Presence of a cardiac pacemaker.\n* Suspected or known porphyria, or known allergy to the study drug, its chemically similar compounds, or photosensitizers.\n* Allergy to silicone.\n* Pregnant or breastfeeding women.\n* Delivery or miscarriage within 6 weeks prior to enrollment.\n* Participation in any other clinical trial within 30 days prior to study treatment.\n* Poor compliance or judged by the investigator to be unsuitable for participation in this clinical study.","FEMALE","18 Days",{"count":20,"type":21},230,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","High-grade squamous intraepithelial lesions (HSIL), encompassing cervical intraepithelial neoplasia grade 2 (CIN2) with p16 positivity and grade 3 (CIN3), are precancerous conditions that require effective intervention. This Phase II study aims to comprehensively evaluate the efficacy, safety, and impact on quality of life of hexaminolevulinate photodynamic therapy (HAL-PDT) compared to immediate surgical treatment in subjects with HSIL.\n\nThis is a prospective, open-label, randomized, controlled, non-inferiority trial. A total of 230 subjects are planned to be enrolled, with 115 subjects allocated to each treatment group (HAL-PDT and surgery).\n\nThe primary endpoint is the pathological regression rate at 12 months, defined as histological findings of normal tissue or low-grade squamous intraepithelial lesions (LSIL) via colposcopy-directed biopsy. Key secondary endpoints include Human Papillomavirus (HPV) clearance rates at 6 and 12 months, pathological regression rate at 6 months, quality of life assessed by the EORTC QLQ-CX24 questionnaire, safety profiles (incidence, severity, and duration of AEs and SAEs, as well as their relationship to the study treatments), and the proportion of subjects developing cervical cancer within 12 months.",[27,28],"Cervical Intraepithelial Neoplasia","Papillomavirus Infections",[30,31,32,33,27,34,35,36,37,38,39,40,41],"HSIL","High-Grade Squamous Intraepithelial Lesions","CIN2","CIN3","HAL-PDT","Hexaminolevulinate Photodynamic Therapy","Photodynamic Therapy","LEEP","Cold Knife Conization","Cervical Cancer Prevention","Non-inferiority Trial","HPV Clearance","NOT_YET_RECRUITING","2026-06-25",{"date":45,"type":46},"2026-06-30","ACTUAL",{"date":48,"type":21},"2026-07-01",{"date":50,"type":21},"2029-06-16",{"name":52,"class":53},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":17,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100639641","priority-study-in-cervical-cancer-100639641","NCT07593066","PRIORITY Study in Cervical Cancer","The PRIORITY Study in Cervical Cancer: A Prospective Multicenter Observational Evaluation of an Integrated Molecular and Digital Model for Diagnostic Prioritization","PRIORITY","Inclusion Criteria:\n\n* Women aged 30 to 65 years\n* Eligible for cervical cancer screening according to national guidelines\n* Able and willing to provide informed consent\n* Able to perform self-sampling or attend clinical evaluation if required\n\nExclusion Criteria:\n\n* Previous diagnosis of cervical cancer\n* History of total hysterectomy (removal of the cervix)\n* Current pregnancy if it precludes study procedures according to clinical judgment\n* Any medical or social condition that, in the opinion of the investigators, would interfere with participation or follow-up",true,"30 Years","65 Years",{"count":66,"type":21},700,"OBSERVATIONAL","The PRIORITY study is a prospective, multicenter observational study designed to evaluate an integrated diagnostic model combining extended molecular self-sampling and digital colposcopy supported by telemedicine for the prioritization of women at risk of cervical cancer.\n\nThe study aims to assess the diagnostic performance, concordance, and clinical utility of this integrated approach in real-world settings, as well as its impact on diagnostic timeliness and patient navigation across different levels of care.\n\nParticipants will undergo standard-of-care evaluation, and data will be collected on molecular test results, colposcopic findings, diagnostic outcomes, and time intervals within the care pathway. No interventions are assigned as part of the study protocol.\n\nThe findings are expected to inform scalable strategies to improve early detection and optimize diagnostic pathways for cervical cancer, particularly in settings with structural and geographic barriers to timely care.",[70,27,71],"Cervical Cancer","HPV Infection",[73,74,75,76,77],"HPV self-sampling","Digital colposcopy","Telemedicine","Diagnostic prioritization","Cervical cancer screening","2026-05-11",{"date":80,"type":46},"2026-05-18",{"date":45,"type":21},{"date":83,"type":21},"2026-12-31",{"name":85,"class":53},"Pontificia Universidad Catolica de Chile",8,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100628452","point-of-care---triage-and-treatment-for-cervical-pre-cancer-100628452","NCT07461818","Point of Care - Triage and Treatment for Cervical Pre-cancer","POINT of CARE - Providing an Innovative New Triage and Treatment Strategy for Cervical Cancer Screening Efficiency","POC","Inclusion Criteria:\n\n* Women aged 30-49 years\n* Non-pregnant (determined by urine pregnancy test)\n* HPV-positive per Ministry of Health (MOH) records\n* Willing to undergo colposcopy and biopsies\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Plans to become pregnant during the study\n* History of LEEP or cervical ablation procedure in the past 5 years\n* History of total hysterectomy (verified by medical record or pelvic evaluation)\n* History of cervical cancer\n* Unable or unwilling to provide a permanent and reliable address\n* Unable or unwilling to provide informed consent","49 Years",{"count":97,"type":21},5000,[99],"NA","This study evaluates a modified two-probe thermal ablation protocol using the IRIS™ device and retrospectively assesses an AI-based Automated Visual Evaluation (AVE) triage algorithm among HPV-positive women in El Salvador. The primary objective is to estimate 1-year cure rates of CIN2+ following treatment. A secondary objective is to evaluate the diagnostic performance of AVE compared with histopathology.",[102,27,103],"Cervical Precancer","Human Papillomavirus Infection",[70],"RECRUITING","2026-03-09",{"date":108,"type":46},"2026-03-11",{"date":110,"type":21},"2026-03",{"date":112,"type":21},"2029-08",{"name":114,"class":53},"Basic Health International, Inc.",1,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":115},"100417220","phase-2-pembrolizumab-for-the-treatment-of-cervical-intraepithelial-neoplasia-100417220","NCT04712851","Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia","A Phase II Open-Label, Single Arm Pilot Study to Evaluate the Safety and Efficacy of Pembrolizumab for High-Grade Cervical Intraepithelial Neoplasia","Inclusion Criteria:\n\n* Female participants who are at least 21 years of age on the day of signing informed consent with active (not yet resected), histologically confirmed diagnosis of CIN grade 2 or 3 or carcinoma in situ (without invasive component) will be enrolled in this study. Subjects with multifocal disease are acceptable\n* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential (WOCBP) OR\n  * A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial\n* Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue\n* Participants must be willing to consent to mid-study biopsy after cycle 2 of treatment if there is an accessible lesion and biopsy is not contraindicated\n* Participants must be willing to consent to either loop electrode excision procedure (LEEP) or cold-knife cone (CKC) at the end of treatment (i.e., after 24 weeks on study), unless surgery is contraindicated at that time\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n* Have normal organ function (with all baseline laboratory assessments in the normal range). Specimens must be collected within 10 days prior to the start of study treatment, except for pregnancy test which must be within 72 hours of cycle 1 of treatment\n\nExclusion Criteria:\n\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n  * Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)\n* Has received prior systemic therapy for CIN including investigational agents within the prior 4 weeks \\[could consider shorter interval for short half-life drugs\\] prior to allocation.\n\n  * Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =\\\u003C grade 1 or baseline. Participants with =\\\u003C grade 2 neuropathy may be eligible.\n  * Note: If participant received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment\n* Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=\\\u003C 2 weeks of radiotherapy) to non-central nervous system (CNS) disease\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n\n  * Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n* Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n\n  * Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ cancers\n* Has severe hypersensitivity (\\>= grade 3) to pembrolizumab and\u002For any of its excipients\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n* Has an active infection requiring systemic therapy\n* Has a known history of human immunodeficiency virus (HIV) infection\n\n  * Note: No HIV testing is required unless mandated by local health authority\n* Has a known history of hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected) infection. Note: no testing for hepatitis B and hepatitis C is required unless mandated by local health authority\n* Has a known history of active TB (Bacillus tuberculosis)\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment\n* Has had an allogenic tissue\u002Fsolid organ transplant","21 Years",{"count":125,"type":21},25,[24],"This phase II trial studies the effect of pembrolizumab on cervical intraepithelial neoplasia. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.",[27,129,130],"Cervical Squamous Cell Carcinoma In Situ","Cervical Squamous Intraepithelial Neoplasia 2","2026-03-06",{"date":133,"type":46},"2026-03-10",{"date":135,"type":46},"2021-06-30",{"date":137,"type":21},"2028-01-31",{"name":139,"class":53},"Jonsson Comprehensive Cancer Center",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":62,"sex":17,"minAge":63,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":157,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":179,"locationsCount":115},"100578795","validation-of-a-lab-free-low-cost-screening-test-for-prevention-of-cervical-cancer-100578795","NCT06815939","Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer","Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer: Automated Visual Evaluation","OPTICS","Inclusion Criteria:\n\n* Women between 30 and 59 years of age\n\nExclusion Criteria:\n\n* Pregnancy at the time of colposcopy\u002Fbiopsy\n* Hysterectomy with surgically absent cervix\n* HPV test in the last 5 years independently of negative or positive result\n* Previous cervical cancer diagnosis or treatment in the last 5 years\n* Lack of willingness or capacity to provide informed consent","59 Years",{"count":150,"type":21},10000,[99],"The purpose of this study is to validate Automated Visual Evaluation (AVE), specifically the CINFinder version developed by DL Analytics, a point-of-care screening and triage diagnostic tool for cervical cancer based on the assessment of digital images through artificial intelligence. Several teams around the world have developed versions of AVE as a triage technology but none as a screening tool.",[154,27,155,156],"Human Papillomavirus (HPV)","Uterine Cervical Neoplasms","Cervical Cancers",[158,70,159,160,161,162,163,164,165,166,167,168,169,170,171,172,155],"Human Papillomavirus","Screening","Neoplasms","Precancerous Conditions","Uterine Diseases","Uterine Cervical Diseases","Genital Diseases, Female","Female Urogenital Diseases and Pregnancy Complications","Urogenital Diseases","Genital Diseases","Uterine Neoplasms","Genital Neoplasms, Female","Urogenital Neoplasms","Neoplasms by Site","Uterine Cervical Dysplasia","2026-01-27",{"date":175,"type":46},"2026-01-29",{"date":177,"type":46},"2025-02-12",{"date":83,"type":21},{"name":180,"class":181},"DL Analytics","INDUSTRY",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":62,"sex":17,"minAge":63,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":196,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":115},"100614110","human-papillomavirus-self-sampling-for-enhancing-cervical-screening-during-the-war-in-ukraine-100614110","NCT07275333","Human Papillomavirus Self-sampling for Enhancing Cervical Screening During the War in Ukraine","Inclusion Criteria:\n\n* Female aged 30-60 years\n* Intact uterus (no prior hysterectomy)\n* Eligible for cervical cancer screening according to local guidelines\n* Able to provide informed consent\n* Able to perform self-sampling at home or at a clinic\n\nExclusion Criteria:\n\n* History of total hysterectomy\n* Pregnancy at the time of enrollment\n* Known diagnosis of cervical cancer\n* Inability or unwillingness to provide informed consent\n* Unable to perform self-sampling or comply with study procedures","60 Years",{"count":190,"type":21},1000,[99],"In 2020, a cervical screening center was established in Zaporizhzhia (Ukraine), initiating a pilot project to evaluate the prevalence of HPV among women in Eastern Ukraine. The findings were intended to lay the groundwork for the Ukrainian Ministry of Health in establishing a structured national screening program. However, all efforts were halted due to the nearby armed conflict, situated just 40 kilometers from the border.\n\nThe World Health Organization's goal to eliminate cervical cancer globally has a gap when it comes to managing cancer control during crises like armed conflicts. We propose a demonstration project to assess whether a simpler, yet modern, cervical cancer control strategy (based on using self-sampling for HPV detection) could also be effective for cervical cancer screening in Zaporizhzhia.\n\nWomen aged 30-60 years who have not had a recent negative HPV test will be invited to participate. Participants receive a self-sampling kit from their primary care provider and can return the sample free of charge to the clinic or community volunteers. All samples are analyzed in accredited laboratories in Zaporizhzhia.\n\nHPV-positive women will receive follow-up care according to national guidelines, including referral to gynecologists for additional tests and treatment if needed. HPV-negative women will be reassured and advised on future screening intervals.\n\nThe study also evaluates how well the screening program can be implemented during conflict conditions. This includes measuring women's acceptance of self-sampling, the willingness of providers to adopt the procedures, and whether the screening process is feasible, practical, and sustainable. Additional process evaluation will explore how the program adapts to challenges such as migration, disrupted health services, and safety concerns.\n\nThis project is conducted through collaboration between Zaporizhzhia State Medical and Pharmaceutical University, the Charitable Foundation \"World Against Cancer,\" and Karolinska Institutet in Sweden, which provides quality assurance support for laboratory procedures. The goal is to establish a safe, effective, and sustainable cervical cancer screening model that can be used in conflict-affected regions and similar settings.\n\nThis work is supported by a grant from the Union for International Cancer Control (UICC), as part of the Reimagining Cancer Research in Europe Initiative.",[70,194,195,27],"Cervical Cancer Screening","Human Papillomavirus (HPV) Infection",[197,198,199,200,201,202,203,204,205,206],"hpv self-sampling","hpv testing","cervical cancer prevention","cervical screening","implementation science","war-affected regions","ukraine","High-risk HPV","self-collection","Screening uptake","2025-12-11",{"date":209,"type":46},"2025-12-18",{"date":211,"type":46},"2025-04-01",{"date":213,"type":21},"2026-08-31",{"name":215,"class":53},"Karolinska Institutet",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":223,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":228,"conditions":229,"keywords":231,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":115},"100530772","phase-1-fenofibrate-in-patients-with-cervical-intraepithelial-neoplasia-and-invasive-cervical-carcinoma-100530772","NCT06191133","Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma","Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma","Inclusion Criteria:\n\n* Participants must have histologically or cytologic confirmed high grade dysplasia or cervical cancer. Histologic types include squamous cell, adenocarcinoma or adenosquamous cell carcinoma.\n* Participants must be eligible for surgical management with LEEP, CKC or hysterectomy or chemoradiation\n* Age ≥ 18 years\n* Normal liver function (AST, ALT, bilirubin within institutional normal limits).\n* Participants must be English speaking\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants with active liver disease, including primary biliary cirrhosis and unexplained, liver function abnormality\n* Participants with severe kidney impairment (CrCl ≤30 mL\u002Fmin calculated using Cockcroft-Gault), or end-stage kidney disease on dialysis\n* Participants with preexisting gallbladder disease including active gallstones\n* Known hypersensitivity to fenofibrate or fenofibric acid\n* Participants that are pregnant or breast feeding due to unknown risk to developing fetus\u002Finfant. Please note: Participants of child-bearing potential (have had menses within the past year or have not had total hysterectomy) are actively screened for pregnancy prior to diagnostic procedures and screened again prior to treatment.","18 Years",{"count":225,"type":21},24,[227],"PHASE1","Normally, p53 helps prevent tumors from forming in the body. Early studies have shown that Fenofibrate, a cholesterol-lowering drug, can restore normal function to p53 and can change the metabolism of HPV-positive tumors in a way that stops the growth of tumors. The purpose of this study is to understand how Fenofibrate can be used to treat HPV-positive cervical cancers and cervical dysplasia. Researchers will examine collected tissue samples and investigate various genes and proteins to see whether Fenofibrate has an effect on HPV-positive cervical cancers and cervical dysplasia.",[27,230],"Invasive Cervical Cancer",[232],"Fenofibrate","2025-09-29",{"date":235,"type":46},"2025-10-02",{"date":237,"type":46},"2024-11-20",{"date":239,"type":21},"2026-11-30",{"name":241,"class":53},"Lindsay Ferguson, MD",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":62,"sex":250,"minAge":223,"maxAge":64,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":255,"conditions":256,"keywords":263,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":115},"100459767","phase-4-immunogenicity-of-gardasil-9-hpv-vaccine-in-people-living-with-hiv-100459767","NCT05266898","Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV","Prospective Observational Immunogenicity Trial of Gardasil-9 HPV Vaccine in People Living With Adequately Managed HIV","AGO-Gard","Inclusion Criteria:\n\n* HIV seropositive\n* immune intact (CD4+ T cell count in peripheral blood \\>200 cells\u002Fml)\n* HIV controlled (peripheral blood HIV viral load \\\u003C1,000 genome copies\u002FmL)\n* Stable on antiretroviral regimen for ≥3 months\n* Gardasil-9 naive and age ≤45 OR\n* documented receipt of 3 doses of Gardasil-4 or Gardasil-9 HPV vaccine\n\nExclusion Criteria:\n\n* Medical contraindication for vaccination (vaccine-naive arm only)\n* Women who are pregnant\n* Acute illness\n* Taking chronic steroids, \\>0.5mg\u002Fkg prednisone or equivalent\n* Taking immune modulating medications\n* Received blood transfusion\u002Fblood products within the past 6 months\n* Recipients of other vaccine products within the past month\n* Inability to provide informed written consent","ALL",{"count":252,"type":21},250,[254],"PHASE4","The primary objective of this study is to determine the magnitude and breadth of the serum antibody response to the nonavalent HPV vaccine (Gardasil-9) in adults with well-controlled HIV infection.\n\nThe secondary objectives of the study are to observe short term clinical outcomes of prevalent HPV genotype-specific anogenital infections in adults living with HIV who complete the three-dose Gardasil-9 vaccine series, and to determine the protection afforded by Gardasil vaccine over time in previously vaccinated adults living with HIV.\n\nThe clinical hypothesis is that adults with virologically controlled HIV mount a serum antibody response to the nonavalent HPV vaccine that is comparable to HIV negative counterparts. We also postulate that HPV vaccination will provide short-term clinical benefit against HPV infections and disease associated with vaccine genotypes and continuing protection against vaccine genotypes of HPV over time.",[257,258,259,260,27,261,262],"Papillomavirus Vaccines","Human Immunodeficiency Virus","Papillomavirus Infection","Serology","Anal Intraepithelial Neoplasia","Oral Cavity Infection",[264,265,266],"Gardasil-9 HPV vaccine","human papillomavirus","human immunodeficiency virus","2025-04-15",{"date":269,"type":46},"2025-04-18",{"date":271,"type":46},"2022-11-30",{"date":273,"type":21},"2026-06",{"name":275,"class":53},"Louisiana State University Health Sciences Center in New Orleans",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":250,"minAge":223,"maxAge":4,"enrollmentInfo":282,"targetDuration":284,"studyType":67,"phases":4,"briefSummary":285,"conditions":286,"keywords":291,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":307},"100461149","the-organ-transplant-recipient-hpv-and-skin-cancer-study-100461149","NCT05284877","The Organ Transplant Recipient HPV and Skin Cancer Study","Inclusion Criteria for OTRs:\n\n* Patients aged ≥18 years\n* Solid organ transplantation recipients, i.e. kidney-, liver-, lung-, and heart transplant recipients\n* Stable immunosuppressive treatment for ≥3 months\n* No signs of acute graft rejection\n* Patients who reside in Denmark\n* Informed written consent obtained\n\nExclusion Criteria for OTRs:\n\n* Patients with concomitant bone marrow transplantation\n* Full hysterectomy\n\nInclusion Criteria for Control group:\n\n* Able patients aged ≥18 years\n* No known immunosuppressive therapy or -condition\n* Patients who reside in Denmark\n* Informed written consent obtained\n\nExclusion Criteria for Control group:\n\n\\- Full hysterectomy",{"count":283,"type":21},1500,"12 Months","Solid organ transplant recipients (OTRs) receive lifelong immunosuppressive therapy, which puts them at increased risk of cutaneous and mucosal cancers. In particular, OTRs have increased risk of skin cancer and cancers caused by human papillomavirus (HPV), including cervical cancer and oropharyngeal cancer. There is currently limited knowledge on risk factors for HPV infection and skin cancer in OTRs, and limited knowledge on the natural history of HPV infection and cervical neoplasia in OTRs compared with immunocompetent controls. With a continuously increasing number of OTRs, there is a growing need to improve our understanding of the long-term reactions to immunosuppression.\n\nThe overall aim of this study is to investigate long term effects of immunosuppression on cutaneous and mucosal epithelium in Danish OTRs, including the risk of skin dysplasia and skin cancer, cervical and oral HPV infection and HPV-related dysplasia and cancer in OTRs.\n\nThis study will be designed as a prospective observational cohort study based on clinical data and data from nationwide Danish registries. A total of 600 female OTRs, 300 male OTRs and 600 female controls will be included from Danish dermatology departments.\n\nThe study aims to provide knowledge relevant for improving prevention of skin- and HPV-related cancers in OTRs, including personalized screening recommendations according to individual patient risk.",[287,288,289,71,27,70,290],"Solid Organ Transplant Recipient","Skin Cancer","Skin Dysplasia","HPV-Related Malignancy",[292,293,294,295,296,297,298],"Organ transplant recipient","Skin cancer","Skin dysplasia","Human papillomavirus","HPV-related dysplasia","HPV-related cancer","HPV","2025-03-27",{"date":211,"type":46},{"date":302,"type":46},"2022-03-10",{"date":304,"type":21},"2043-03",{"name":306,"class":53},"Merete Haedersdal",3,{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":17,"minAge":315,"maxAge":316,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":323,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":336},"100456906","hpv-based-screening-among-women-23-29-years-of-age-100456906","NCT05229679","HPV-based Screening Among Women 23-29 Years of Age","Evaluation of Organized Human Papilloma Virus (HPV) Screening of 23-29-year-old Women","Inclusion Criteria:\n\n* Women ages 23-29 invited to screening.\n\nExclusion Criteria:\n\n* Women who do not show up for screening or do not consent.","23 Years","29 Years",{"count":318,"type":21},180000,[99],"The aim of the trial is to determine whether organized screening with primary HPV analysis provide higher cancer protection in the age group 23-29 years compared to primary cytology.",[322,27,70],"Human Papilloma Virus",[324,325,326,327],"Organized screening","HPV vaccination","Human papilloma virus","Prevention","2025-03-18",{"date":330,"type":46},"2025-03-19",{"date":332,"type":46},"2020-11-16",{"date":334,"type":21},"2038-12-31",{"name":215,"class":53},2,{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":17,"minAge":223,"maxAge":64,"enrollmentInfo":345,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":4},"100582675","study-on-novel-strategies-for-cervical-cancer-screening-using-photoelectric-detection-and-epigenetic-procotol-100582675","NCT06866392","Study on Novel Strategies for Cervical Cancer Screening Using Photoelectric Detection and Epigenetic Procotol","Study on Novel Strategies for Cervical Cancer Screening Using Photoelectric Detection Combined with Epigenetic Procotol","CC-AZ","Inclusion Criteria:\n\n1. Women between the ages of 18 and 65 who have already had sex life\n2. HPV16, 18 positive or high-risk HPV infection with cytology ≧ASC-US\n3. No history of cervical cancer and cervical physical therapy, a complete cervix\n4. No menstrual period, no sexual activity and vaginal medication within 48 hours\n5. The vagina or cervix is not in a stage of acute inflammation\n6. Willing to participate in the study with full informed consent\n\nExclusion Criteria:\n\n1. Cervical dysplasia (congenital malformation or double uterus, etc.)\n2. History of cervical treatment (coning, ablation, or photodynamic therapy)\n3. There are definite immunosuppression conditions, such as HIV infection or organ transplantation\n4. Patients with severe bleeding diseases such as coagulation abnormalities or photosensitive diseases (such as porphyria, lupus erythematosus, etc.)\n5. A history of radiation or chemotherapy (e.g., pelvic radiation therapy) with cancer at other sites\n6. The patient is in pregnancy or puerperium\n7. The other conditions of this study were not considered appropriate by the researchers",{"count":346,"type":21},4200,"A national multicenter, open randomized controlled study was conducted. It is planned to invite 30 multi-center units across the country to compete for enrollment, and each multi-center will enroll 140 patients meeting colposcopic indications (70 in the conventional group and 70 in the experimental group), totaling 4200 patients. Enrolled subjects were randomly divided into two groups. Methylation test + colposcopic biopsy was performed in the conventional group, and clinical follow-up was performed according to the methylation results; in the experimental group, methylation test + colposcopic biopsy +OITS was performed, and clinical follow-up was performed according to the methylation results and OITS results. To verify the effectiveness of methylation tests and OITS in screening for CIN2+, whether they can reduce missed diagnosis of CIN2+, whether they can flag excessive colposcopic procedures, and the value of clinical follow-up for cervical lesions.",[70,27],"2025-03-04",{"date":351,"type":46},"2025-03-10",{"date":353,"type":21},"2025-03-15",{"date":355,"type":21},"2028-03-15",{"name":357,"class":53},"Peking Union Medical College Hospital",{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":17,"minAge":365,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":22,"phases":368,"briefSummary":369,"conditions":370,"keywords":371,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":336},"100445291","low-cost-imaging-technology-for-global-prevention-of-cervical-cancer-100445291","NCT05078528","Low-cost Imaging Technology for Global Prevention of Cervical Cancer","Low-cost Mobile Colposcopy and Confocal Imaging for Global Prevention of Cervical Cancer","Inclusion Criteria:\n\n* Women \\>25 years of age;\n* Women undergoing colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia;\n* Women of childbearing potential must have a negative urine or blood pregnancy test;\n* Ability to understand and willingness to provide informed consent by signing specific Informed Consent Document.\n\nExclusion Criteria:\n\n* Women under 25 years of age;\n* Women who have undergone hysterectomy with removal of the cervix;\n* Women with known allergy to proflavine or acriflavine;\n* Women who are pregnant or nursing at the time of enrollment;\n* Incapacitated women or in vulnerable situations or who are not willing to give consent;","25 Years",{"count":367,"type":21},1060,[99],"Cervical cancer remains the first or second leading cause of cancer death among women in many low-and middle-income countries. Cervical cancer prevention programs in low-resource settings are hampered by a lack of personnel with appropriate clinical expertise, lack of pathology services, and lack of associated infrastructure. There is an urgent need for appropriate diagnostic tools to enable accurate screening and diagnosis in low-resource settings. The purpose of this study is to develop and validate a low-cost Multimodal Mobile Colposcope (MMC) for global cervical cancer prevention programs. This new device will combine the imaging capabilities of a mobile colposcope with the microscopic imaging capabilities of a fiber-optic confocal imaging probe.",[27],[372,373,374],"image analysis","cancer prevention","cervical intraepithelial neoplasia","2025-02-04",{"date":377,"type":46},"2025-02-06",{"date":379,"type":46},"2021-09-20",{"date":381,"type":21},"2025-12-03",{"name":383,"class":53},"Barretos Cancer Hospital",{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":62,"sex":17,"minAge":223,"maxAge":4,"enrollmentInfo":392,"targetDuration":394,"studyType":67,"phases":4,"briefSummary":395,"conditions":396,"keywords":397,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":336},"100563042","adjuvant-vaccination-after-conization-for-the-treatment-for-cervical-dysplasia-100563042","NCT06611020","Adjuvant VaccInation After Conization for the Treatment for CervicAL Dysplasia","The Role of Adjuvant VaccInation After Conization for the Treatment for Cervical Dysplasia","VITAL","Inclusion Criteria:\n\n* Treatment of HPV-related disease\n\nExclusion Criteria:\n\n* Previous HPV vaccination",{"count":393,"type":21},600,"2 Years","HPV vaccination has emerged as a strategy to reduce the risk of recurrence oafter excisional treatment. However, only few data are aviable. In this trial the investigators aim to assess the role of HPV vaccination in women traeted for HPV-related lesions",[27],[298],"2024-09-25",{"date":400,"type":46},"2024-09-26",{"date":402,"type":46},"2020-01-01",{"date":404,"type":21},"2027-01-31",{"name":406,"class":53},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":414,"enrollmentInfo":415,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":5},"100460935","effect-of-hpv-integration-on-prognosis-of-young-women-with-cin2-in-china-100460935","NCT05282095","Effect of HPV Integration on Prognosis of Young Women With CIN2 in China","Effect of HPV Integration on Prognosis of Young Women With CIN2 in China: A Multi-center Cohort Study in China","Inclusion Criteria:\n\n* Female, 18 years of age or older and 45 years of age or younger, with a desire to conceive;\n* Diagnosed with HSIL (CIN2) or HSIL (CIN2-3) via cervical tissue biopsy within the past 3 months, and has not undergone cervical surgery, physical, or medication treatment;\n* The lesion area under colposcopy is less than 50% of the total cervical area within the past 3 months;\n* Plans for 12-month follow-up observation for CIN2, with no surgical, physical, or medication treatment if the disease does not progress;\n* Understands and voluntarily agrees to participate in the 12-month follow-up of this study, and signs the informed consent form.\n\nExclusion Criteria:\n\n* Cervical status at the time of enrollment as determined by colposcopy within the past three months is Type III transformation zone;\n* Pregnant or lactating;\n* History of malignant reproductive tract tumors;\n* History of hysterectomy, cervical surgery, or pelvic radiation therapy;\n* Physical therapy to the cervix within 24 months prior to enrollment;\n* The subject has a severe immune system disease that is active;\n* Long-term use of contraceptives within 12 months prior to enrollment;\n* Vaginal medication or irrigation within 72 hours prior to sampling (can re-enroll for sampling 3 days after cessation);\n* Sexual intercourse within 24 hours prior to sampling (can re-enroll for sampling 24 hours after cessation);\n* Received treatment for genital tract infections, HPV, or other STD pathogens within the past month (can re-enroll one month after cessation of treatment);\n* Used antibiotics or vaginal microecological improvement products within the past month (can re-enroll one month after cessation of use);","45 Years",{"count":416,"type":21},300,"Clinically, cervical precancerous lesion is one of the important diseases that endanger the life safety and fertility of young women. Women with histopathologically confirmed CIN2 need regular HPV, cervical cytology, and colposcopic biopsy if necessary to assess the outcome and progression of the disease. In this study, we intend to visit Fujian Maternal and Child Health Hospital, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science \\& Technology and other hospitals, including 300 CIN2 participants aged 45 and below diagnosed by histopathology, and collect the remaining cervical secretions and cervical exfoliated cell samples after clinical examination, even if you do not participate in this clinical study. In clinical diagnosis, treatment and follow-up, it is also necessary to collect the above specimens for relevant medical tests. Therefore, it is of great clinical and scientific significance to explore the role of HPV integrated detection in predicting the prognosis of young women with CIN2.",[27,71,419,420],"Virus Integration","HSIL, High Grade Squamous Intraepithelial Lesions","2024-09-12",{"date":423,"type":46},"2024-09-19",{"date":425,"type":46},"2022-06-01",{"date":427,"type":21},"2026-05-31",{"name":429,"class":53},"Fujian Maternity and Child Health Hospital",{"id":431,"slug":432,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":11,"sex":17,"minAge":223,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":115},"100558963","cervical-cytology-dna-methylation-for-cervical-cancer-screening-100558963","NCT06557954","Cervical Cytology DNA Methylation for Cervical Cancer Screening","Cervical Cytology DNA Methylation for Cervical Cancer Screening: A Real Word Study","Inclusion Criteria:\n\n* Aged 18 years or older\n* With uterine cervix intact\n* Given consents to participate the study\n* With detailed follow-up outcomes\n\nExclusion Criteria:\n\n* Not meeting all of the inclusion criteria",{"count":438,"type":21},30000,"Cervical cancer represents one of the foremost causes of cancer-related morbidity and mortality among women worldwide. Given the current limitations, such as the low specificity of human papillomavirus (HPV) testing and the relatively low sensitivity of cytological examinations, there is a pressing need for a novel, non-invasive, safe, and precise screening method. This study aims to undertake a multicentre, real-world investigation, incorporating at least 10 sub-centres and enrolling 30,000 participants. Histopathological examination results will serve as the 'gold standard' for evaluating the screening efficacy of human PAX1 and JAM3 gene methylation assays (PAX1m\u002FJAM3m), HPV testing, and cytological examinations. Furthermore, the study seeks to elucidate the relationship between DNA methylation levels and persistent HPV infection, while also assessing the applicability of PAX1m\u002FJAM3m across diverse clinical settings. By focusing on alterations in DNA methylation levels within cervical exfoliated cells as the primary research trajectory, this study aspires to furnish novel insights and theoretical foundations for the prevention and management of cervical cancer, targeting PAX1m\u002FJAM3m. The ultimate objective is to facilitate the clinical implementation of an enhanced cervical cancer screening protocol, thereby addressing the deficiencies of current screening methodologies, achieving greater precision in cervical cancer screening, and effectively reducing the incidence of cervical cancer while mitigating the risks of overdiagnosis and overtreatment.",[70,441,442,103,27,443],"DNA Methylation","Cytology","Cancer Screening","2024-08-15",{"date":446,"type":46},"2024-08-19",{"date":448,"type":21},"2024-09-01",{"date":450,"type":21},"2026-10-01",{"name":452,"class":53},"Lei Li",{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":17,"minAge":223,"maxAge":64,"enrollmentInfo":460,"targetDuration":4,"studyType":22,"phases":461,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":115},"100553884","a-multicenter-randomized-controlled-study-of-photoelectric-detection-in-cervical-cancer-screening-100553884","NCT06491888","A Multicenter Randomized Controlled Study of Photoelectric Detection in Cervical Cancer Screening","A Multicenter Randomized Controlled Study of Fluorescence Photoelectric Cervical Lesion Image Detector in Cervical Cancer Screening","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years old, ≤ 65 years old, with a complete cervix without deformity.\n* 2\\. Have clear cervical cancer screening results, meet HPV16\u002F18 (+) or high-risk HPV (+), and cervical cytology results ≥ ASC-US.\n* 3\\. Fully informed and agreed to participate in the study.\n* 4\\. No history of cervical cancer disease and cancer in other parts.\n\nExclusion Criteria:\n\n* 1\\. Cannot meet all Inclusion Criteria.\n* 2\\. There is clear immunosuppression, such as HIV infection or organ transplantation, etc., and the vagina or cervix is in the acute inflammation stage。\n* 3\\. There are serious bleeding diseases or photosensitive diseases such as abnormal coagulation.",{"count":346,"type":21},[99],"The main purpose of this study is to verify the accuracy of the fluorescence photoelectric cervical lesion image detector relative to the pathological gold standard and the detection rate of CIN 2 +, as well as the significance of it as a shunt tool before colposcopy through a randomized controlled study.\n\nThe secondary objectives were to compare the relative pathological accuracy of the fluorescence photoelectric cervical lesion image detection results with the HPV detection results and cytological results, and to compare the lesion area displayed by the fluorescence photoelectric cervical lesion image detector with the lesion area that appeared after traditional colposcopy chemical staining.\n\nIn this study, 4200 subjects who have been evaluated and can be enrolled (these subjects have the indication of referral to colposcopy) will be included in the study, and they will be divided into two groups according to the principle of randomization. The histological results were obtained after routine colposcopy and biopsy. The experimental group first underwent colposcopy and biopsy after the judgment of the fluorescent photoelectric cervical lesion image detector to obtain histological results. Finally, the accuracy of the relative pathological results, the detection rate of CIN2 +, negative predictive value and positive predictive value of the two groups were compared.",[464,27,465,466],"Uterine Cervical Cancer","High Grade Squamous Intraepithelial Lesions","Low Grade Squamous Intraepithelial Lesions","2024-08-13",{"date":444,"type":46},{"date":470,"type":21},"2024-08",{"date":472,"type":21},"2025-07",{"name":452,"class":53},{"id":475,"slug":476,"hasResults":11,"nctId":477,"briefTitle":478,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":11,"sex":17,"minAge":223,"maxAge":4,"enrollmentInfo":481,"targetDuration":394,"studyType":67,"phases":4,"briefSummary":483,"conditions":484,"keywords":488,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":499,"leadSponsor":501,"locationsCount":503},"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":482,"type":21},410,"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).",[485,486,487,27],"Cervical High Grade Squamous Intraepithelial Lesion","Cervical Intraepithelial Neoplasia Grade 2\u002F3","CIN 2\u002F3",[489,490,491,492,493,494],"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":497,"type":46},"2023-09-11",{"date":425,"type":46},{"date":500,"type":21},"2026-12",{"name":502,"class":53},"Catharina Ziekenhuis Eindhoven",15,{"id":505,"slug":506,"hasResults":11,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":11,"sex":17,"minAge":365,"maxAge":511,"enrollmentInfo":512,"targetDuration":4,"studyType":22,"phases":513,"briefSummary":514,"conditions":515,"keywords":519,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":115},"100478504","diagnostic-cervical-conization-for-persistent-infection-or-integration-of-hpv-100478504","NCT05510830","Diagnostic Cervical Conization for Persistent Infection or Integration of HPV","A Study of the Value of Diagnostic Cervical Conization for Persistent Infection or Integration of Human Papillomavirus","Inclusion Criteria:\n\n1. The patients are referred to colposcopy and biopsy examinations due to abnormal cervical screening results with no precancerous lesions discovered by pathology.\n2. The cervical precancerous lesions are highly suspected by clinicians with one or more following risk factors:\n\n   * The course of HPV type 16\u002F18 persistent infection is more than two years.\n   * The integration reads of HPV is more than 15.\n   * The impression of colposcopy indicates precancerous lesions.\n   * The cervical TCT indicates ASC-H\u002FHSIL\u002FSCC\u002FAGC-FN\u002FAIS\u002FAC.\n\nExclusion Criteria:\n\n1. Pregnant women.\n2. Vaginal intraepithelial neoplasia is highly suspected by colposcopy and pathological examinations.\n3. The patients are suffering malignant tumors of other system and have not been cured.\n4. There is acute inflammation of the lower genital or anal tract.\n5. The patients' health will be severely harmed by the colposcopy and cervical conization due to some circumstances such as severe insufficiency of liver and kidney function, blood diseases and acute inflammation of other systems.","70 Years",{"count":252,"type":21},[99],"For the patients with cervical persistent infection or integration of HPV, we has designed a program to perform cervical conization for certain patients to earlier and better diagnose and cure the diseases of HPV infection and related cervical intraepithelial neoplasia\u002Fcancer.",[516,517,27,70,518],"Human Papilloma Virus Infection","Human Papilloma Virus Integration","Cervical Conization",[520,521,522],"HPV persistent infection","HPV integration","diagnostic cervical conization","2022-09-07",{"date":525,"type":46},"2022-09-08",{"date":527,"type":21},"2022-10",{"date":529,"type":21},"2030-01",{"name":531,"class":53},"Tongji Hospital",{"id":533,"slug":534,"hasResults":11,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":541,"conditions":542,"keywords":544,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":115},"100422667","conservative-management-of-hsil-in-patients-with-future-pregnancy-aspiration-100422667","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)",{"count":540,"type":21},200,"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.",[27,543,172],"Squamous Intraepithelial Lesions of the Cervix",[545,546,547],"H-SIL","Conservative management","CIN","2021-03-04",{"date":550,"type":46},"2021-03-05",{"date":552,"type":46},"2021-03-03",{"date":554,"type":21},"2027-12-31",{"name":556,"class":53},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau",{"id":558,"slug":559,"hasResults":11,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":563,"eligibilityCriteria":564,"healthyVolunteers":11,"sex":17,"minAge":223,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":22,"phases":567,"briefSummary":569,"conditions":570,"keywords":571,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":4},"100350840","phase-3-impact-on-disease-relapse-of-hpv-vaccination-in-women-treated-with-leep-for-cervical-intraepithelial-neoplasia-hope9-100350840","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",{"count":566,"type":21},1220,[568],"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.",[27],[70,374,257],"2020-11-04",{"date":574,"type":46},"2020-11-05",{"date":576,"type":21},"2020-12",{"date":578,"type":21},"2028-05",{"name":580,"class":53},"Alessandro Ghelardi"]