[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"uterine-cervical-dysplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:uterine-cervical-dysplasia":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,63,100],{"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":33,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100636954","phase-2-phase-ii-study-of-dysplasix-intravaginal-suppositories-in-patients-patients-with-high-risk-hpv-and-mild-cervical-cytologic-abnormalities-100636954",false,"NCT07572396","Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities","A Phase II, Randomized, Double-blind, Placebo-Controlled, Proof of Concept Study to Assess the Safety and Efficacy of Dysplasix™ Intravaginally-Administered Suppositories in Patients With High-Risk Human Papillomavirus (Hr-HPV) as Determined by HPV Testing, and Accompanied by Either (1) Atypical Squamous Cells of Undetermined Significance (ASC-US) or (2) Low-Grade Squamous Intraepithelial Lesions (LSIL), as Determined by Cytology","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be eligible to enroll in the study:\n\n1. Participants capable of giving informed consent\n2. Females, ages 18 to 65 years old at the time of signature of the informed consent form.\n3. Participants who are able to correctly self-administer the intravaginal suppositories\n4. One or more hr-HPV oncotypes as confirmed by HPV test\n5. Participants with ASCUS or LSIL abnormalities as confirmed by cytology\n6. Immune competent\n7. Participants of childbearing potential must have a negative pregnancy test at screening.\n8. Participants of childbearing potential must agree to use appropriate contraception or abstain from sexual intercourse for the duration of the study\n9. Participants must not have received a recent HPV vaccination and must abstain from HPV vaccination until the end of study\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. Presence of HSIL at screening cytology\n2. Evidence of glandular abnormalities (AGC\u002FAIS) at screening cytology\n3. BMI below 16\n4. Pregnant or nursing females\n5. Evidence of vaginal\u002Fvulval comorbidities, specifically, common sexually transmitted or vaginal infections, and bloodborne pathogens\n6. Using a vaginal contraceptive ring\n7. History of irregular menstrual cycles or routine intermenstrual bleeding\n8. Active autoimmune disease\n9. Taking prohibited concomitant medications\n10. Concurrent malignancy except for non-melanoma skin lesions\n11. Active participation in another clinical trial involving therapeutic intervention (unless ending within 30 days of screening date)","FEMALE","18 Years","65 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to learn if an investigational vaginal suppository therapy works to treat low-grade cervical lesions (ASC-US and LSIL) associated with high-risk human papillomavirus (hr-HPV) infection in women. It will also learn about the safety and tolerability of this investigational therapy. The main questions it aims to answer are:\n\n* Does the investigational therapy lead to regression of cervical lesions?\n* Does the investigational therapy help clear hr-HPV infection?\n* Do any adverse effects occur from using this medical product?\n\nResearchers will compare the investigational therapy to a placebo (a look-alike substance that contains no active drug) to see if the investigational therapy works.\n\nParticipants will:\n\n* Be screened for hr-HPV, cervical abnormalities, and other conditions to be assessed for eligibility\n* Self-administer 15 doses of the investigational therapy or placebo as a vaginal suppository over 19 calendar days\n* Attend scheduled clinic visits for examinations, testing, and monitoring for a period of two months\n* Undergo assessments to evaluate cervical lesion status, hr-HPV infection, and safety outcomes\n* Keep a daily diary of investigational therapy use and associated information",[27,28,29,30,31,32],"High-risk HPV (Any Strain)","LSIL, Low Grade Squamous Intraepithelial Lesion","ASC-US","HPV Infection","Cervical Abnormalities","Uterine Cervical Dysplasia",[34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"hpv","human papillomavirus","CIN1","LSIL","EGCG","Quinine Sulfate","abnormal Pap","ASCUS","gynecology","precancerous lesions","atypical squamous cells","low grade squamous intraepithelial lesions","Epigallocatechin gallate","women's health","abnormal cytology","cervical cytology","RECRUITING","2026-05-12",{"date":53,"type":54},"2026-05-14","ACTUAL",{"date":56,"type":21},"2026-04-30",{"date":58,"type":21},"2027-01-27",{"name":60,"class":61},"Amplexd Therapeutics, Inc.","INDUSTRY",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":62},"100562054","developing-a-combined-molecular-screening-and-triage-test-for-cervical-cancer-in-self-samples-100562054","NCT06598176","Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples","Developing a Combined Molecular Screening and Triage Test for Cervical Cancer Based on Human Papillomavirus (HPV) Detection, Quantification, Genotyping and DNA Methylation in Self-samples (COMBISCREEN)","COMBISCREEN","Inclusion Criteria:\n\n* Female\n* 25 until 64 years old\n* Diagnosed with cervical cancer (CIN3+, irrespective of stage) OR in need of conization (irrespective of diagnostic or therapeutic purposes)\n* Has not started any form of cancer treatment prior to study enrollment\n* Written informed consent must be obtained from patient\n* Is able to understand the information brochure and what the study is about\n\nExclusion Criteria:\n\n* Women that underwent hysterectomy\n* Pregnant women or 6 weeks post-partum\n* Treatment for cervical (pre)cancer in the last 6 months before participation in the study\n* Participating in another interventional clinical study (where e.g., a medical device, drug, or vaccine is evaluated) at the same time of participating in this study. Participation in another observational or low-interventional clinical study at the same time is allowed.\n* Unable to give informed consent\n* Patient has severe anaemia\n* Patient received blood transfusion two weeks before sample collection\n* Blood sampling would compromise patients' overall health\n* Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.\n* Patients who are alcoholic or drug abusers\n* Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, or is not in the best interest of the patient to participate, in the opinion of the investigator.","25 Years","64 Years",{"count":74,"type":21},100,[76],"NA","The goal of the COMBISCREEN project is to develop a fully molecular cervical screening and triage approach that is applicable on self-samples, which are an easily accessible and non-invasive source of biomarkers. The project allows a one-step screening and triage modality and thereby identifies women with clinically relevant disease that are in need of treatment.",[79,32,80,81],"Uterine Cervical Neoplasm","Human Papilloma Virus","HPV-Related Cervical Carcinoma",[83,84,85,86,87,88,89],"biomarker","first-void urine","vaginal sample","screening","triage","self-sampling","prevention","2024-09-13",{"date":92,"type":54},"2024-09-19",{"date":94,"type":54},"2024-03-28",{"date":96,"type":21},"2037-02-28",{"name":98,"class":99},"Universiteit Antwerpen","OTHER",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":62},"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":108,"type":21},200,"OBSERVATIONAL","Conservative management of high-grade squamous intraepithelial lesions (HSILs) seems safe and justified in young women (\\\u003C30 years), but evidence is insufficient on whether it is also advisable for older women.\n\nThis study will be conducted to analyze spontaneous HSIL regression rates in women of reproductive age and establish whether conservative HSIL management could be safely recommended to women of childbearing potential, irrespective of age.\n\nThis is a single-center prospective observational study that will include consecutive women of reproductive age, referred to a tertiary hospital due to HSIL between March 2021 and December 2025, who prefer conservative management rather than immediate cervical conization.\n\nAll patients will be followed-up regularly with colposcopy, cytology, human papillomavirus (HPV) testing and biopsies. In case their lesions progress or HSIL persists after 24 months of follow-up, conization will be indicated. Rates of spontaneous regression or resolution, as well as progression rates, will be assessed. Furthermore, the association between potential predictive factors and HSIL resolution will be analyzed.",[112,113,32],"Cervical Intraepithelial Neoplasia","Squamous Intraepithelial Lesions of the Cervix",[115,116,117],"H-SIL","Conservative management","CIN","2021-03-04",{"date":120,"type":54},"2021-03-05",{"date":122,"type":54},"2021-03-03",{"date":124,"type":21},"2027-12-31",{"name":126,"class":99},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"]