[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-grade-squamous-intraepithelial-lesions-hsil\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-grade-squamous-intraepithelial-lesions-hsil":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100606031","a-clinical-study-on-the-evaluation-of-bd114-for-the-treatment-hpv-16-related-cervical-hsil-100606031",false,"NCT07170254","A Clinical Study on the Evaluation of BD114 for the Treatment HPV-16-Related Cervical HSIL","An Open-Label, Two-Arm, Non-Randomized Clinical Study On The Safety And Efficacy Of Instantaneous CRISPR\u002FCas9 Gene Editing Therapy For Treating Chinese Patients With HPV-16-Related High-Grade Squamous Intraepithelial Lesions (HSIL)","Inclusion Criteria:\n\n1. Female, aged 25 to 50 years, without childbearing demand;\n2. Confirmed histopathological evidence of cervical HSIL (CIN3) at the screening period or within 1 month prior to screening;\n3. Confirmed cervical HPV-16 positive by HPV test during the screening period or within 1 month prior to screening, without other high-risk HPV types detected;\n4. Complete visibility of both the squamocolumnar junction (SCJ Types 1\u002F2) and the upper margin of acetate-white epithelium or suspected HSIL lesions under colposcopy examine during the screening period or within 1 month prior to screening;\n5. No evidence of precancerous lesions or malignancy by endocervical curettage (ECC) ;\n6. The biopsy sampling of cervical lesions are performed;\n7. Visible residual cervical lesions after screening biopsy;\n8. Willing to maintain abstinence or use a highly effective contraceptive method (oral contraceptives, injections, implants, or barrier methods) for women of childbearing potential (WOCBP) from enrollment until Week 36, or her partner undergone surgical sterilization (e.g., vasectomy);\n9. Good compliance to protocol-specified procedure in study duration assessed by investigator;\n10. Voluntarily participating in the study and willing to provided signed informed consent.\n\nExclusion Criteria:\n\n1. Positive detection of antibodies or viral test of human immunodeficiency virus (HIV), or hepatitis B virus (HBV), or hepatitis C virus (HCV), or Treponema pallidum (TP) at screening;\n2. Confirmed histopathologically epithelial carcinoma, glandular carcinoma or precancerous lesions in the endometrium at screening;\n3. Confirmed histopathologically or macroscopically high-grade intraepithelial neoplasia or invasive carcinoma in the vulva, vagina or anus at screening;\n4. HSIL with partial location in cervical canal and incomplete colposcopic visualization ;\n5. Undergone the treatment for cervical HSIL within 4 weeks prior to screening;\n6. Vaccination history of any therapeutic HPV vaccine;\n7. Family history of malignancy, or a history\u002Fcurrent presence of any malignant tumor;\n8. Severe uncontrolled diseases of major organs, including but not limited to: acute myocardial infarction, stroke, liver cirrhosis, severe kidney disease, diabetes mellitus, chronic obstructive pulmonary disease (COPD), hematologic disorders, psychiatric disorders, etc;\n9. Pregnant (a positive urine or serum pregnancy test) or lactating women;\n10. Participating in another drug or device clinical trial at screening, or participated in one within 3 months prior to screening;\n11. The history of any form of gene and\u002For cell therapy;\n12. Drug abuse or alcohol addiction no compliance to protocol-specific procedure;\n13. Any other condition unsuitable for participating this study judged by the investigator.","FEMALE","25 Years","50 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is intented to evaluate the safety, and tolerability and preliminary efficacy of Instantaneous CRISPR\u002FCas9 Gene Editing Therapy (BD114 virus-like particle, also BD114) for the treatment of high-grade squamous intraepithelial lesions (HSIL) associated with HPV-16 infection.",[27],"High-grade Squamous Intraepithelial Lesions (HSIL)",[29,30,31],"High-grade squamous intraepithelial lesions","HPV-16 infection","Gene Editing Therapy","RECRUITING","2025-09-05",{"date":35,"type":36},"2025-09-12","ACTUAL",{"date":38,"type":21},"2025-09",{"date":40,"type":21},"2026-12",{"name":42,"class":43},"Shanghai BDgene Co., Ltd.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":44},"100570931","predicting-treatment-failure-in-hsil-patients-with-positive-margins-after-conization-via-detection-of-pax1-methylation-100570931","NCT06713655","Predicting Treatment Failure in HSIL Patients with Positive Margins After Conization Via Detection of PAX1 Methylation","Multicenter Study on PAX1 Methylation for Predicting Lesion Persistence\u002FRecurrence in HSIL Patients with Positive Margins After Cervical Conization","Inclusion Criteria:\n\n* Age greater than 25 years and less than 55 years;\n* First-time cervical conization (cold knife conization or loop electrosurgical excision procedure);\n* Postoperative pathology showing HSIL (CIN2 or CIN3);\n* Positive margins for HSIL (CIN2 or CIN3) in conization specimen.\n\nExclusion Criteria:\n\n* The presence of other malignant tumors or precancerous lesions;\n* Lack of willingness for follow-up;\n* Pregnant or breastfeeding women;\n* Unable or unwilling to complete follow-up examinations;\n* History of prior cervical disease treatment (surgical or physical therapy);\n* Presence of immune system disorders.","26 Years","54 Years",{"count":55,"type":21},800,"OBSERVATIONAL","The goal of this multicenter, observational study is to evaluate whether methylation testing of paired box gene 1 (PAX1) can better predict and diagnose recurrence or persistent disease in patients with positive margins after cervical conization for high-grade squamous intraepithelial lesion (HSIL). The main question it aims to answer is:\n\nCan PAX1 gene methylation testing provide a more accurate and effective prediction and diagnosis of cervical disease recurrence\u002Fpersistence in addition to existing methods? Participants will be managed according to the latest clinical guidelines, and during follow-up, a non-invasive test, PAX1 gene methylation testing, will be added.",[27,59],"Cervical Conization",[61,62,63,64,65,66],"cervical intraepithelial neoplasia","conization","positive margins","cervical cancer","treatment failure","residual\u002Frecurrent disease","NOT_YET_RECRUITING","2024-12-03",{"date":70,"type":36},"2024-12-06",{"date":72,"type":21},"2024-12",{"date":74,"type":21},"2028-07",{"name":76,"class":77},"Women's Hospital School Of Medicine Zhejiang University","OTHER"]