[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hpv-related-cervical-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hpv-related-cervical-carcinoma":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,85,110,145,176,208,229],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":47,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100491983","phase-2-e7-tcr-t-cell-immunotherapy-for-human-papillomavirus-hpv-associated-cancers-100491983",false,"NCT05686226","E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers","A Phase II Trial of T Cell Receptor Gene Therapy Targeting Human Papillomavirus ( HPV) 16 E7 for HPV-Associated Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Histologically or cytologically confirmed metastatic or refractory\u002Frecurrent HPV-16+ cancer.\n2. Tumor and\u002For blood with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.\n3. HLA-A\\*02:01 allele as determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A\\*02) but the HLA-A\\*02:01 allele type must be confirmed prior to apheresis.\n4. Measurable disease as assessed by RECIST Criteria Version 1.1.\n5. Age ≥ 18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening.\n7. Must have received prior first line standard therapy or have declined standard therapy.\n8. Standard treatment options for first and second-line therapy must be presented and formally declined (Appendix VII).\n9. Patients with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients must be fully recovered from surgery.\n10. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.\n11. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n12. Seronegative for HIV antibody, hepatitis B antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by RT-PCR for hepatitis C (HCV) RNA must be negative.\n13. Participants must have organ and marrow function as defined below:\n\n    1. Leukocytes \\> 3,000\u002FmcL\n    2. Absolute neutrophil count \\> 1,500\u002FmcL\n    3. Platelets \\> 100,000\u002FmcL\n    4. Hemoglobin \\> 9.0 g\u002FdL\n    5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    6. Serum aspartate transferase (AST) (SGOT)\u002Falanine transaminase (ALT) (SGPT) \\\u003C 2.5 x upper limit of normal (ULN)\n    7. Calculated creatinine clearance (CrCl) \\>50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).\n    8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage.\n14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the E7 TCR cells. Adverse events from prior therapy must have resolved to ≤ grade 1 according to CTCAE Version 5.0 or have demonstrated clinical stability for the protocol.\n15. Participants must be able to understand and be willing to sign the written informed consent document.\n16. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) or NIH protocol 16C0061 (Rutgers 192202) for biospecimen collection study.\n\nNote: Participants may have undergone minor surgical procedures with the past three weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations at the time of treatment that would limit compliance with study requirements.\n2. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.\n3. History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.\n4. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:\n\n   1. Clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or\n   2. Age ≥ 50 years old\n5. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, then they may be reevaluated.\n6. Subjects with HLA-A\\*02:01 damaging mutation or allele loss detected by clinical or research genomic profiling will not be eligible.\n7. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study.\n8. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.\n9. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n10. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.\n11. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:\n\n    1. Carcinoma in situ\n    2. Cutaneous skin cancers requiring only local excision\n    3. Low grade non-muscle invasive bladder cancer\n    4. Low grade prostate cancer\n\n    Participants with prior or concurrent malignancy that do not meet the above criteria are excluded.\n12. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n13. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.\n14. Current treatment with another investigational agent.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"Cervical Cancer","Throat Cancer","Oropharynx Cancer","Anal Cancer","Vulva Cancer","Vaginal Cancer","Penile Cancer","Metastatic Cancer","HPV-Related Malignancy","HPV-Related Carcinoma","HPV-Related Cervical Carcinoma","HPV-Related Squamous Cell Carcinoma","HPV-Related Adenocarcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma","HPV-Associated Vaginal Adenocarcinoma","HPV-Related Adenosquamous Carcinoma","HPV-Related Endocervical Adenocarcinoma","HPV-Related Anal Squamous Cell Carcinoma","HPV-Related Penile Squamous Cell Carcinoma","HPV-Related Vulvar Squamous Cell Carcinoma","HPV Positive Rectal Squamous Cell Carcinoma",[48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71],"Chimeric antigen receptors (CAR-T)","Tumor infiltrating lymphocyte","TCR-T","immunotherapy","T cell","adoptive cell therapy","cellular therapy","gene therapy","human papillomavirus","HPV","E7","T cell receptor","TCR","E7 TCR","lymphocyte","cell therapy","cervical cancer","oropharyngeal cancer","anal cancer","vulvar cancer","vaginal cancer","penile cancer","tumor infiltrating lymphocytes (TIL)","TIL therapy","RECRUITING","2026-06-10",{"date":75,"type":76},"2026-06-12","ACTUAL",{"date":78,"type":76},"2023-03-07",{"date":80,"type":20},"2027-01-01",{"name":82,"class":83},"Christian Hinrichs","OTHER",3,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100428322","detecting-hpv-dna-in-anal-and-cervical-cancers-100428322","NCT04857528","Detecting HPV DNA in Anal and Cervical Cancers","Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy","Inclusion Criteria:\n\n* Stage I-III anal cancer or stage I-IVA cervical cancer that is p16+ based on immunohistochemistry.\n* Age ≥ 18 years\n* Planned to undergo radiation therapy as definitive treatment, with or without concurrent systemic therapy\n\nExclusion Criteria:\n\n* Anal carcinoma not associated with HPV-16, 18, 31, 33, or 35 will be removed from the\n* Planned to undergo radiation therapy as an adjuvant or post-operative therapy",{"count":19,"type":20},"OBSERVATIONAL","This is a research study for individuals who have cancer associated with human papillomavirus (HPV) and are being treated with radiation as part of standard care for their cancer. Doctors leading this study will use blood tests to find out if they can detect the HPV virus in the blood of study participants before, during, and after radiation treatment. They will also collect blood and archival tumor tissue (from a previous biopsy) to perform other tests in the future that could provide more information about HPV-associated cancers and how they respond to treatment. Participation in this study will last approximately 2 years.",[26,29,43,36,35,96],"Uterine Cervical Cancer",[57,98,64,66,99],"radiation treatment","uterine cervix","2026-03-02",{"date":102,"type":76},"2026-03-04",{"date":104,"type":76},"2020-10-06",{"date":106,"type":20},"2027-11-15",{"name":108,"class":83},"University of Chicago",2,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":119,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":144},"100540678","phase-1-a-study-to-evaluate-lenti-hpv-07-immunotherapy-against-hpv-cervical-or-oropharyngeal-cancer-100540678","NCT06319963","A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer","An Open-Label Phase 1\u002F2a Clinical Trial to Evaluate the Safety, Immunogenicity, and Preliminary Efficacy of a Lentiviral Vector-Based Therapeutic Vaccine Against Human Papilloma Virus (Lenti-HPV-07) in Participants With HPV-Associated Oropharyngeal Squamous Cell Cancer or Cervical Cancer","Inclusion Criteria:\n\n* histologically confirmed invasive HPV-related oropharyngeal or cervical cancer\n* ECOG performance status of 0 or 1\n* adequate hepatic, renal, pulmonary, and bone marrow\u002Fhematological function\n\nExclusion Criteria:\n\n\\- with seropositivity for HIV, active hepatitis C virus (HCV) infection, or hepatitis B (HBV) infection",{"count":118,"type":20},72,[120,23],"PHASE1","The goal of this clinical trial is to learn about the safety and efficacy of a potential new treatment called Lenti-HPV-07 in patients with a cancer induced by Human Papilloma Virus (HPV).\n\nThe main questions aim to answer are:\n\n* Is Lenti-HPV-07 safe?\n* Does Lenti-HPV-07 induce an immune response?\n\nParticipants will be assigned to a group based on their cancer type\n\n* either study drug group A: recurrent and\u002For metastatic cancer\n* or study drug group B: newly diagnosed with locally advanced cancer\n\nAfter they finish the study treatment, they will be followed for up to 1 year. Follow-up visits will occur via clinic visits or phone calls 4 weeks after the last study treatment and then quarterly for up to 1 year.",[36,39],[124,26,125,126,127,128,129,130,131,132,133],"HPV16","Oropharyngeal cancer","Immuno-oncotherapy","Head and Neck Cancers","T-cell vaccine","Lentiviral Vector","Anti-tumor immunity","Early E- and E7 antigens","HPV18","Human Papillomavirus","2026-01-29",{"date":136,"type":76},"2026-02-02",{"date":138,"type":76},"2024-08-08",{"date":140,"type":20},"2026-12",{"name":142,"class":143},"Theravectys S.A.","INDUSTRY",4,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":21,"phases":155,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":175},"100565292","phase-2-dynamic-ctdna-assessment-in-cervical-and-anal-canal-tumors-optimizing-follow-up-and-clinical-outcomes-100565292","NCT06640283","Dynamic ctDNA Assessment in Cervical and Anal Canal Tumors: Optimizing Follow-up and Clinical Outcomes","Dynamic Assessment of ctDNA in Patients With Cervical and Anal Canal Tumors to Optimize Follow-up and Clinical Outcomes in the Brazilian Unified Health System (SUS)","ANA","Inclusion Criteria:\n\n1. Histological diagnosis of anal canal or cervical cancer.\n2. Documented presence of HPV.\n3. Locally confined or locally advanced disease, defined as:\n\n   1. Anal canal carcinoma stage I to III, according to American Joint Committee on Cancer (AJCC) 8th edition;\n   2. Cervical carcinoma stage I B2 to IV A, according to AJCC 8th edition.\n4. Indication for definitive treatment with radiotherapy, with or without concomitant chemotherapy.\n5. Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) 0 - 1.\n6. Age ≥ 18 years.\n7. Signing of the Informed Consent Form (ICF).\n8. HIV-positive patients may be included if Cluster of Differentiation 4(CD4) count is greater than or equal to 200.\n9. Patients may participate in other concurrent studies, as long as they do not involve interventions related to the treatment of the underlying cancer.\n\nExclusion Criteria:\n\n1. Patients with unequivocal distant metastasis at diagnosis.\n2. For participants with positive ctDNA after treatment, those candidates for participation in Phase II will be excluded if there is unequivocal radiological progression in the first imaging exam after the completion of radiotherapy (with or without chemotherapy) or routine indication for salvage surgery immediately after the conclusion of definitive treatment.\n3. Need for recurrent blood transfusions, such as weekly frequency.\n4. Another uncontrolled disease representing a life risk, as determined by medical judgment.\n5. Personal history of another active invasive malignant neoplasm in the last 5 years, except for non-melanoma skin carcinomas and in situ carcinomas.\n6. Pregnant individuals.\n7. Active opportunistic infection or disease.\n8. History of autoimmune diseases.",{"count":154,"type":20},150,[23],"After definitive radiotherapy (RT) treatment (with or without chemotherapy), cervical and anal canal neoplasms frequently exhibit disease persistence or recurrence. Due to the local inflammatory process post-treatment, response assessment by imaging (current gold standard) is limited, often necessitating multiple follow-ups and repeated invasive biopsies. Conventional follow-up is complex and costly, requiring equipment from secondary and tertiary services, trained radiologists, and patient exposure to radiation and contrast.\n\nIn this context of human papillomavirus(HPV)-related neoplasms, recent studies have demonstrated the role of ctDNA (circulating tumor DNA) in assessing the risk of recurrence or disease progression, providing a rationale for using the tool in two fronts:\n\n* Optimizing follow-up based on serial monitoring of ctDNA;\n* Selecting patients with positive ctDNA after RT, who are at high risk of recurrence, for treatment intensification.\n\nMonitoring with ctDNA as a standalone follow-up tool in cases evolving with negative ctDNA after RT has the potential to replace imaging exams, being a minimally invasive test performed on a peripheral blood sample. Currently, ctDNA testing has expensive methodologies not available in the Unified Health System (SUS). This project aims to develop a methodology for ctDNA evaluation focused on HPV ctDNA research that is low-cost and executable in SUS, as well to assess the accuracy of this test in the population with HPV-related tumors.\n\nAdditionally, we will evaluate whether the early introduction of immunotherapy in patients with positive ctDNA after definitive treatment can increase cure rates. Immunotherapy already has a well-defined role in the treatment of metastatic HPV-related neoplasms. Recently, the use of anti-programmed death-1 (anti-PD1) has also shown benefits in patients with locally advanced cervical cancer with a high risk of recurrence who are candidates for chemoradiotherapy (CRT). Therefore, its use focused on HPV-related tumors, as well as a better understanding of which patients benefit from this strategy, warrants further investigation.",[35,96,158,43,36],"Anal Canal Cancer",[57,160,161,162,163,164,165],"ctDNA","Cervical tumors","Anal canal tumors","Molecular diagnosis","Diagnostic test","Biomarkers","2025-12-18",{"date":168,"type":76},"2025-12-24",{"date":170,"type":76},"2025-03-14",{"date":172,"type":20},"2027-01",{"name":174,"class":83},"Instituto do Cancer do Estado de São Paulo",1,{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":183,"minAge":17,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":21,"phases":187,"briefSummary":189,"conditions":190,"keywords":194,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":175},"100520089","comparison-of-5-ala-photodynamic-therapy-and-co2-laser-for-treating-persistent-low-grade-cervical-lesions-with-high-risk-hpv-infection-100520089","NCT06052033","Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection","The Effect of 5-aminolaevulinic Acid Photodynamic Therapy Versus C02 Laser in the Treatment of Persistent Cervical Low-grade Squamous Intraepithelial Lesions With High-risk HPV Infection:A Non-randomized Controlled Trail Study","Inclusion Criteria:\n\n1. Aged 18-65 years old with a history of sexual activity.\n2. Subclinical infected individuals who have been confirmed as HR-HPV positive (if there is the same positive type in the typing test) for more than 1 year using HPV typing test, HPV E6\u002FE7 mRNA test, HPV DNA test, and cervical triple step diagnostic procedure (cytology colposcopy histopathology).\n3. Patients diagnosed with LSIL by pathological examination of cervical biopsy under colposcopy with an interval of more than 1 year.\n4. No fundamental diseases of important organs.\n5. Agree to receive treatment and\u002For follow-up according to regulations and sign an informed consent form.\n6. There has been no history of using other drugs related to HPV infection in the past 3 months.\n\nExclusion Criteria:\n\n1. HR-HPV persistent infection.\n2. A total hysterectomy has been performed.\n3. Concomitant endometrial cancer, ovarian cancer, and other reproductive tract tumors.\n4. Complicated with abnormal heart, liver, and kidney functions, immune dysfunction, or immune system diseases such as systemic lupus erythematosus (SLE).\n5. Using drugs such as immunosuppressants, antiviral agents, and glucocorticoids.\n6. Pregnant and lactating women.\n7. Acute reproductive tract inflammation.\n8. Diabetes patients with uncontrolled blood sugar.\n9. Patients who do not receive full treatment and follow-up.\n10. Those who fail to sign the informed consent form.","FEMALE","65 Years",{"count":186,"type":20},40,[188],"NA","Non-RCT clinical trial comparing 5-ALA photodynamic therapy and CO2 laser for persistent high-risk HPV-related low-grade cervical lesions.",[36,191,192,193],"Low-Grade Squamous Intraepithelial Lesions","HPV Infection","Photodynamic Therapy",[195,196,197,198],"high-risk hpv infection","hpv persistent","Lsil","cervical lesions","2025-05-12",{"date":201,"type":76},"2025-05-13",{"date":203,"type":76},"2023-09-11",{"date":205,"type":20},"2025-06-30",{"name":207,"class":83},"First Affiliated Hospital of Wenzhou Medical University",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":183,"minAge":17,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":21,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":175},"100503005","phase-1-phase-1-dose-escalation-study-of-flubhpve6e7-in-hpv16-infected-women-100503005","NCT05829629","Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women","Randomised, Double-blind, Placebo-controlled Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women with NILM, ASC-US, LSIL or Low-grade CIN","Inclusion Criteria:\n\n* Females, 18-49 years of age with HPV16 infection and cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1)\n* HPV16 infection has been confirmed at least twice by a validated HPV test separated by at least 3 months\n* Satisfactory colposcopy\n* No clinically significant out of range haematological, renal or hepatic laboratory tests\n* Normal screening ECG or screening ECG with no clinically significant findings, as judged by the investigator\n* Negative serum pregnancy test at screening\n* Agree to use a reliable form of contraception during the whole study period.\n* Provides written informed consent\n\nExclusion Criteria:\n\n* Any vaccination within 6 weeks of day 0\n* Active significant viral infections including influenza, CMV, and EBV within 30 days of receiving study treatment\n* Co-infection with hepatitis B, hepatitis C, or HIV or having other immune deficient states\n* Current Bacterial Vaginosis (BV) infection\n* Current high-grade cervical intraepithelial neoplasia (CIN2\u002F3)\n* Prior history of or current malignancy, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN), atypical glandular cells (AGC), adenocarcinoma in situ (AIS) or any suspicion of either micro-invasive or invasive disease\n* Pregnancy, breastfeeding\n* Influenza-like illness (ILI) within 3 months of day 0\n* Known hypersensitivity to oseltamivir or any of its components\n* Any anatomical condition of the cervix, including that resulting from previous cervical surgery, congenital malformation or other condition, that would interfere with a complete evaluation of the cervix\n* Current pelvic inflammatory disease, cervicitis, or other gynaecological infection as per colposcopy and clinical examination\n* Serious, concomitant disorder, including active systemic infection requiring treatment\n* Presence of acute or chronic bleeding or clotting disorder, or use of blood thinners within 2 weeks of day 0\n* A proven or suspected autoimmune disease\n* Immunosuppression including any concurrent condition requiring the continued use of systemic or topical steroids, or the use of immunosuppressive agents, disease modifying doses of anti-rheumatic drugs, and biologic disease modifying drugs. Any immunosuppressive agents containing corticosteroids or monoclonal antibodies specific for the treatment of obstructive airway, ear or vestibular diseases are permissible.\n* Acute or history of Herpes genitalis\n* Prior major surgery within 4 weeks of day 0\n* Administration of any blood product within 3 months of enrolment\n* Any current significant cardiac, hepatic or renal disease or history of clinically significant, medically unstable disease\n* Any current or history of neurological disease including history of seizures\n* Participation in another experimental protocol\u002Fuse of investigational drug during the prior two months","49 Years",{"count":19,"type":20},[120],"BS-02 is a randomised, double-blind, placebo-controlled, phase 1 dose escalation study to assess the safety, tolerability and immunogenicity of FluBHPVE6E7, in women infected with HPV-16. with cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1).",[192,36],"2025-02-12",{"date":222,"type":76},"2025-02-14",{"date":224,"type":76},"2023-09-12",{"date":226,"type":20},"2025-11",{"name":228,"class":143},"BlueSky Immunotherapies GmbH",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":183,"minAge":237,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":21,"phases":241,"briefSummary":242,"conditions":243,"keywords":247,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":175},"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":240,"type":20},100,[188],"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.",[244,245,246,36],"Uterine Cervical Neoplasm","Uterine Cervical Dysplasia","Human Papilloma Virus",[248,249,250,251,252,253,254],"biomarker","first-void urine","vaginal sample","screening","triage","self-sampling","prevention","2024-09-13",{"date":257,"type":76},"2024-09-19",{"date":259,"type":76},"2024-03-28",{"date":261,"type":20},"2037-02-28",{"name":263,"class":83},"Universiteit Antwerpen"]