[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"human-papilloma-virus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:human-papilloma-virus":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,44,72,99,121,153,182,209,237,256,281,309,340,360,382,406,438,460,487,508,527,550,582,605,641],{"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":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100412057","phase-2-merck-iit-rrp-pembro-and-lenvatinib-100412057",false,"NCT04645602","Merck IIT: RRP Pembro and Lenvatinib","A Pilot Study of Lenvatinib in Combination With Pembrolizumab in HPV-associated Recurrent Respiratory Papillomatosis Patients","Inclusion Criteria:\n\n\\- Participants must have histologically or cytologically confirmed respiratory papillomas with radiologic evidence of lung involvement. Subjects can have measurable or non-measurable\\* pulmonary disease based on RECIST 1.1. Non-measurable disease based on RECIST 1.1 is defined as lesions with a short axis less than 10 mm\n\n* For those patients with non-measurable pulmonary disease, participants must have disease at other sites such as the larynx and trachea and must have undergone \\> 3 surgical procedures over a 12-month period.\n* Be required to provide tissue from a newly obtained biopsy of a lesion or an archived specimen. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to the first dose of study drug. Subjects for whom newly obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the PI.\n* Have confirmed human papillomavirus-associated lesions based on in-situ hybridization testing and\u002For polymerase chain reaction which may be performed on a newly obtained biopsy or archived sample.\n* Age ≥18 years.\n* ECOG performance status of 0 to 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  \\---- Absolute neutrophil count (ANC) ≥1500\u002FμL\n\n  \\---- Platelets ≥100 000\u002FμL\n\n  \\---- Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL (a)\n  * Creatinine OR Measured or calculated (b) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × institutional ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n  * Total bilirubin ≤1.5 × institutional ULN OR direct bilirubin ≤ institutional ULN for participants with total bilirubin levels greater than or equal to 1.5× institutional ULN\n  * AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × institutional ULN for participants with liver metastases)\n  * TSH Institutional normal limit\n  * Free T4 Institutional normal limit\n  * Amylase less than or equal to 1.5 x institutional ULN\n  * Lipase less than or equal to 1.5 x institutional ULN\n  * International normalized ratio (INR) OR prothrombin time (PT)\n  * Activated partial thromboplastin time (aPTT)\n\n    * 1.5 × institutional ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n  * ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n\n    1. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC)transfusion within last 2 weeks.\n    2. Creatinine clearance (CrCl) should be calculated per institutional standard. -- Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* Adequately controlled blood pressure with or without antihypertensive medications defined as systolic BP ≤ 140 mmHg and diastolic BP ≤ 90 mmHg at screening with no change in antihypertensive medications within 1 week prior to screening.\n* Female subject of childbearing potential must have a negative serum pregnancy test within 28 days of the first dose of study drug\\*. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n  \\*Please refer to the study calendar for requirements regarding a pregnancy test 24 hours prior to receiving any dose of study medication upon subject enrollment into the study.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n  * Is not a WOCBP as defined below. OR\n  * Is a WOCBP and must be willing to use 2 methods of birth control, or abstain from heterosexual activity during the intervention period and for at least 120 days after the last dose of pembrolizumab or 30 days post lenvatinib, whichever occurs last.\n\nWomen of childbearing potential are those who have not been surgically sterilized or have not been free from menses for greater than 1 year. The methods of surgical sterilization include having had a hysterectomy (removal of the uterus), bilateral oophorectomy (removal of both ovaries), tubal ligation (having your tubes tied), and transvaginal occlusion (blocking the tubes with a coil). The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention - A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.\n\n* If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months (or 120 days) after completion of pembrolizumab\n* Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of Lenvatinib:\n\n  * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.\n\nOR\n\n• Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:\n\n* Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n* Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed\n\n  * Ability to complete Patient Medication and Blood Pressure diaries by themselves or with assistance.\n  * Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study enrollment.\n\nNote: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.\n\nNote: If participant received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment. Withhold lenvatinib for at least 7 days prior to elective major surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. Endoscopic debridement of RRP lesions is NOT considered a major surgery.\n\n* Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.\n* Has had major surgery within 3 weeks prior to first dose of study interventions. Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.\n* Has received a live vaccine within 30 days prior to the first dose of study drug.\n\nExamples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n\n* Is currently participating in or has participated in a study of an investigational agent within 4 weeks prior to the first dose of study treatment. 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 known additional malignancy that is progressing or has required active treatment within the past 3 years. NOTE: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, well-differentiated thyroid cancer, follicular lymphoma, carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) invasive cancer derived from RRP, or other indolent malignancy not requiring active treatment are not excluded.\n* History of allergic reactions (greater than or equal to Grade 3) attributed to compounds of similar chemical or biologic composition to pembrolizumab or lenvatinib 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.\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. 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 RNA 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 urine protein greater than or equal to 1 g\u002F24 hours. Note: Participants with proteinuria \\> 2+ (greater than or equal to100 mg\u002FdL) on urine dipstick testing (urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria.\n\nNote: Urine dipstick is the preferred method for testing urinary protein, however, urinalysis may be used if the use of urine dipsticks is not feasible.\n\n* Electrolyte abnormalities that have not been corrected.\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia associated with hemodynamic instability and requiring medical treatment at screening. Note: Medically controlled arrhythmia would be permitted.\n* Has a LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO).\n* Prolongation of QTcF interval to \\>480 msec, as calculated by either the Bazett or Fridericia formula, as per institutional standard.\n* Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. The degree of tumor invasion\u002Finfiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy.\n* Has a known history of colitis.\n* Has clinically significant gastrointestinal malabsorption syndrome or any other condition that might affect the absorption of lenvatinib.\n* Has preexisting greater than or equal to Grade 3 gastrointestinal or non-gastrointestinal fistula\n* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n* Has a known history of posterior reversible encephalopathy syndrome (PRES).\n* Participants with 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* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\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. Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pembrolizumab and\u002For lenvatinib, and breastfeeding should be discontinued.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This research study is studying Lenvatinib in combination with Pembrolizumab in people with human papillomavirus (HPV)-associated recurrent respiratory papillomatosis (RRP).\n\nThe names of the study drugs involved in this study are:\n\n* Pembrolizumab\n* Lenvatinib",[26,27,28],"Human Papilloma Virus","Recurrent Respiratory Papillomatosis","Pulmonary Disease",[26,27,30],"Pulmonary Involvement","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2025-07-18",{"date":39,"type":20},"2027-12",{"name":41,"class":42},"Yale University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":43},"100312777","phase-1-hpv-specific-immune-lymphocytes-hpv-ctls-in-the-treatment-of-hpv-100312777","NCT03351855","HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of HPV","Phase I\u002FII and Multicenter Trial of HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of Human Papilloma Virus (HPV) Infection","Inclusion Criteria:\n\n1. Written, informed consent obtained prior to any study-specific procedures.\n2. Evidence of HPV virus activation (viral DNA) or high risk of HPV infection.\n3. Not suitable for routine treatment or invalid to antiviral drugs.\n4. Patients with viral disease symptoms and confirmed by biopsy, regardless of the level of virus DNA.\n5. Age less than 75 years.\n6. Did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics.\n7. Initial hematopoietic reconstitution: neutrophils (ANC) ≥ 1,000\u002Fmm\\^3, platelet (PLT) ≥ 1,000\u002Fmm\\^3.\n8. Proper renal and hepatic functions (ULN denotes \"upper limit of normal range\"): Creatinine ≤ 2\\*ULN, Bilirubin ≤ 2\\*ULN, SGOT\u002F SGPT ≤ 3\\*ULN.\n9. If HPV-CTL is not from the patient's own, then the provider of HPV-CTL needs to meet the following criteria:\n\n   * did not receive chemotherapy or radiotherapy within 4 weeks prior to blood collection, and did not take any steroids for the previous week, did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics.\n   * white blood cells ≥ 3,500 \u002F μl, lymphocytes ≥ 750 \u002F μl.\n10. Human immunodeficiency virus (HIV) test was negative.\n\nExclusion Criteria:\n\n1. Subject or the donor of BMT recipient infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.\n2. Subject is albumin-intolerant.\n3. Subject with life expectancy less than 8 weeks.\n4. Subject participated in other investigational somatic cell therapies within past 30 days.\n5. Subject with positive pregnancy test result.","6 Months","75 Years",{"count":54,"type":20},100,[56,23],"PHASE1","The purpose of this clinical trial is to evaluate the safety and efficacy of IV-infused autologous or allogenic HPV-CTLs.",[26],[60,61,62],"Human papilloma virus","Cytotoxic lymphocyte","HPV-CTL","2026-06-18",{"date":65,"type":35},"2026-06-23",{"date":67,"type":35},"2026-06-01",{"date":69,"type":20},"2030-12-31",{"name":71,"class":42},"Shenzhen Geno-Immune Medical Institute",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100641565","developing-and-implementing-hpv-screened-100641565","NCT07657104","Developing and Implementing HPV SCREENED","Developing and Implementing HPV SCREENED (Self-Collection REach and ENgagement in Emergency Departments) to Improve Cancer Equity","Inclusion Criteria:\n\n* biological women,\n* no prior hysterectomy or cervical cancer,\n* not pregnant,\n* last Pap \\>3 years, last co-test \\>5 years, or last HPV alone test \\>5 years,\n* speak English or Spanish,\n* has a working cellphone,\n* NJ residency\n* ED patient\n\nExclusion Criteria:\n\n* currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy);\n* previous hysterectomy;\n* previous diagnosis of cervical cancer;\n* current menses",true,"FEMALE","30 Years","65 Years",{"count":54,"type":20},[85],"NA","This study will assess the feasibility of implementing HPV self-sampling as a primary cervical cancer screening strategy for under-screened women in the emergency department (ED). Eligible participants will receive education and an HPV self-sampling kit to complete in the ED. Individuals with HPV-positive results will be guided to follow-up care at a local clinic.",[88,26],"Cervical Cancer Screening","NOT_YET_RECRUITING","2026-06-17",{"date":63,"type":35},{"date":93,"type":20},"2026-07-01",{"date":95,"type":20},"2027-09-30",{"name":97,"class":42},"Rutgers, The State University of New Jersey",2,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":80,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":43},"100547906","hpv-equity-study-exploring-cervical-cancer-control-in-scotland-for-women-with-experience-of-priority-risks-100547906","NCT06414057","HPV Equity Study: Exploring Cervical Cancer Control in Scotland for Women With Experience of Priority Risks","Inclusion Criteria:\n\nIndividuals will be eligible for participation in components 1 and\u002For 2 if they:\n\n* have a cervix\n* are aged 25-45 years (inclusive)\n* are able to provide informed consent for themself\n\nAnd have experience of either:\n\n* substance use\u002Faddiction\n* living in custodial settings\n* homelessness\n* involvement in transactional sex\n\nExclusion Criteria:\n\nIndividuals will be excluded from participation if they:\n\n* Do not have a cervix due to surgery or other reasons\n* Are known to have completed the full vaccination schedule (as per JCVI criteria for their age and immunocompetency) (Excluded from component 1 (vaccination and HPV screening) only - still able to participate in component 2 (individual interview))\n* Meet any of the vaccine exclusion criteria as set out in the local HPV PGD\n* Have had a confirmed anaphylactic reaction to a previous dose of HPV vaccine.\n* Have had a confirmed anaphylactic reaction to any component of the vaccine. Practitioners must check the marketing authorisation holder's SmPC for details of vaccine components.\n* Have a history of severe (i.e. anaphylactic reaction) to latex where the vaccine is not latex free.\n* Are known to be pregnant.\n* Are suffering from an acute severe febrile illness (the presence of a minor infection is not a contraindication for immunisation).\n\nAdditionally, PGDs advise caution where a neurological condition is believed to be progressing or there is neurological deterioration and therefore, individuals meeting this criteria will be excluded (from component 1 only).","25 Years","45 Years",{"count":108,"type":20},500,"OBSERVATIONAL","Individuals with experience of homelessness, substance use\u002Faddiction, transactional sex, and incarceration experience significant health inequities across a wide range of health conditions. This inequity includes cervical cancer with individuals in these populations less engaged with both routine human papillomavirus (HPV) vaccination and cervical cancer screening programmes, yet also at higher risk of developing cervical cancer.\n\nOpportunistic vaccination is recommended by the Joint Committee on Vaccination and Immunisation for 'other at risk\u002Fvulnerable groups' who may benefit (such as people with experience of transactional sex or incarceration) at clinical discretion. However, there is limited evidence on the feasibility, uptake, attitudes and impact of vaccination in these at-risk groups and no nationally funded programme.\n\nThis mixed methods exploratory study seeks to generate evidence to inform the optimal service design. Core objectives are to: 1) assess the feasibility and acceptability of offering opportunistic HPV vaccination during standard sexual health care to women at high risk of HPV and cervical cancer; 2) identify the type-specific prevalence of HPV among recruited participants; and 3) describe participants' perceptions and experiences of accessing routine HPV vaccination and cervical screening services, and\u002For this opportunistic (research) service.\n\nThe investigators will seek to recruit women with experience of homelessness, substance use\u002Faddiction, transactional sex, and incarceration. The study will include trans-men and non-binary people at risk of cervical cancer with the same risk experiences. Potential participants will be identified prospectively via attendance at specialist sexual health services in Scotland.\n\nParticipants will be offered HPV vaccination and testing, and\u002For an in-depth research interview. Participation can be completed within one clinic visit. The full vaccination course is available via participation (min\u002Fmax does spacing 6\u002F12 months) and participants testing positive for high-risk type HPV can\u002Fwill be followed up in full and supported in accessing treatment.",[26],"2026-06-08",{"date":114,"type":35},"2026-06-09",{"date":116,"type":35},"2025-07-07",{"date":118,"type":20},"2027-10-31",{"name":120,"class":42},"University of Edinburgh",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":79,"sex":129,"minAge":130,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":134,"conditions":135,"keywords":138,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":4},"100556688","blood-biomarkers-based-screening-for-hpv-driven-opc-100556688","NCT06528353","Blood Biomarkers Based Screening for HPV-driven OPC","SCREEN-HPV: Blood Biomarkers Based Screening for HPV-driven OPC","SCREEN-HPV","Inclusion Criteria:\n\n* Aged ≥50 years from the general population\n* Man\n* No previous history of HPV-driven cancer or head neck cancer\n* Willingness to complete follow up visits\n\nExclusion Criteria:\n\n* Aged \\\u003C 50 years\n* Woman\n* History of HPV-driven cancer or head and neck cancer\n* Psychiatric conditions\n* Inability to complete follow up visits\n* Severe medical condition (life expectancy \\\u003C5 years)\n* Previous prophylactic HPV vaccination","MALE","50 Years",{"count":132,"type":20},10000,[85],"The objective of our study is to demonstrate that it is possible to detect and treat human papilloma virus (HPV)-related oropharyngeal cancers (OPC) early using simple blood tests. The success of this strategy will be evaluated by the number of participants positive for both HPV16-E6 serology and HPV circulating tumor DNA (ctDNA) whose early management has allowed the detection of a cancerous lesion and\u002For whose HPV ctDNA results have normalized after surgical intervention. If this study is conclusive, it could pave the way for the implementation of a national screening strategy for HPV-related OPC.",[136,137,26],"Head and Neck Squamous Cell Carcinoma","Anal Cancer",[139,140,141,142,143],"HPV-induced cancer","Head and Neck Cancers","virology","serology","secondary cancer prevention","2026-05-22",{"date":146,"type":35},"2026-05-26",{"date":148,"type":20},"2026-09",{"date":150,"type":20},"2032-09",{"name":152,"class":42},"UNICANCER",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":164,"conditions":165,"keywords":169,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":43},"100573523","phase-1-intratumoral-lidocaine-injection-before-oropharyngeal-cancer-surgery-100573523","NCT06747390","Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery","A Phase I Randomized Controlled Trial of Intratumoral Lidocaine Injection Before Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma","856397","Inclusion Criteria:\n\nPatients 18 years older or more.\n\nHistologically confirmed diagnosis of squamous cell carcinoma of the oropharynx or neck.\n\nClinical T1, T2, T3, or T4 stage disease of the oropharynx (per AJCC 8th Ed).\n\nAny clinical N stage disease (per AJCC 8th Ed).\n\nPatients must be undergoing direct laryngoscopy +\u002F- biopsy at the University of Pennsylvania as part of their work-up for consideration of definitive TORS and selective neck dissection.\n\nPatients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits.\n\nAbility to understand and the willingness to provide written informed consent.\n\n\\---\n\nExclusion Criteria:\n\nPrior external beam radiation therapy to the head and neck.\n\nPrior chemotherapy for head and neck cancer.\n\nTumor invades lateral pterygoid muscle, pterygoid plates, lateral nasopharynx, or skull base or encases carotid artery (i.e. AJCC 7th Ed. T4b for OPSCC).\n\nPresence of distant metastatic disease.\n\nUncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\nKnown history of hypersensitivity to lidocaine or other amide local anesthetics.\n\nPregnant or breastfeeding.",{"count":162,"type":20},30,[56],"Based on evidence that the local anesthetic lidocaine may have anticancer effects, this study will assess the safety and efficacy of intratumoral lidocaine injection at the time of direct laryngoscopy prior to TransOral Robotic Surgery (TORS) and neck dissection for oropharyngeal squamous cell carcinoma (OPSCC). The primary objective of the study is to determine if intratumoral lidocaine injection is safe and causes a major pathologic treatment effect in the primary tumor following surgical resection. The secondary objectives will be to determine if intratumoral lidocaine injection improves locoregional control rates, progression-free survival, metastasis-free survival, and overall survival compared to no injection.",[166,167,26,168],"Oropharyngeal Squamous Cell Carcinoma (OPSCCA)","Oropharyngeal Cancer","Squamous Cell Carcinoma",[170,171,167,26,168,172],"TransOral Robotic Surgery (TORS)","Oropharyngeal Squamous Cell Carcinoma","Lidocaine","2026-05-10",{"date":175,"type":35},"2026-05-12",{"date":177,"type":35},"2025-04-23",{"date":179,"type":20},"2028-11-01",{"name":181,"class":42},"Ryan Carey",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":189,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":21,"phases":192,"briefSummary":193,"conditions":194,"keywords":198,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":207,"locationsCount":43},"100534015","phase-1-use-of-acu-d1-in-hpv-associated-vulvar-and-perianal-lesions-in-people-with-hiv-100534015","NCT06233331","Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV","Phase I Dose Escalation Study of the Use of ACU-D1, a Topical Proteasome Inhibitor in HPV Associated Vulvar and Perianal Lesions in People With HIV","Inclusion Criteria:\n\n* Age 21 years and older\n* HIV-infected\n* Able to provide informed consent\n* Biopsy-proven HSIL disease of the vulvar and perianal region with a total disease volume of 3 cm or greater\n* Combined antiretrovirals (cART) adherence\n* CD4 count \\> 200 cells\u002Fml\n* Sustained undetectable viral load for ≥ 3 months\n* If applicable, on reliable birth control such as combined oral contraceptive pills (OCP), bilateral tubal ligation (BTL), a long-acting reversible contraceptive, or Depo-Provera (birth control shot)\n* Willingness to conform to study requirements\n* Reliable follow-up and contact information\n* No risk factors or clinical suspicion for micro-invasive disease and absence of medical condition that interferes with the conduct of the study in the investigator's opinion\n\nExclusion Criteria:\n\n* Currently pregnant (confirmed by collecting urine for HCG pregnancy test) or lactating","21 Years",{"count":191,"type":20},9,[56],"The goal of this study is to test the maximum tolerated dose of ACU-D1 in HIV-positive people with HPV-associated vulvar and perianal lesions. The main questions it aims to answer are:\n\n* The maximum tolerated dose of ACU-D1\n* Safety and tolerability of topical ACU-D1\n* Whether topical ACU-D1 induces p53 and p53-mediated downstream signaling (including p21 induction) in HPV-related lesions\n* Whether topical ACU-D1 enhances markers of immunity in HPV-infected HIV-positive individuals\n\nParticipants will be asked\n\n* To apply ACU-D1 on the lesions twice daily for 4 weeks\n* 3 biopsies will be performed at the screening and 3 at the end of 4 weeks.",[26,195,196,197],"Human Immunodeficiency Virus","Anal Intraepithelial Neoplasia","High-Grade Squamous Intraepithelial Lesions",[199,200,196],"HIV","HPV","2026-05-05",{"date":203,"type":35},"2026-05-08",{"date":205,"type":20},"2026-06",{"date":39,"type":20},{"name":208,"class":42},"Emory University",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":21,"phases":218,"briefSummary":219,"conditions":220,"keywords":223,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},"100477019","phase-2-a-study-of-reduced-radiation-therapy-and-standard-of-care-chemotherapy-in-people-with-hpv-positive-throat-cancer-100477019","NCT05491512","A Study of Reduced Radiation Therapy and Standard-of-Care Chemotherapy in People With HPV-Positive Throat Cancer","Major Radiation Dose De-Escalation Concurrent With Chemotherapy for Human Papilloma Virus Associated Oropharyngeal Carcinoma","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) from biopsy, surgical resection or excisional biopsy regardless of margin status.\n\n  1. Squamous cell carcinoma of the neck of unknown primary is allowed with excision biopsy of a lymph node (or core biopsy) or consent from the PI or co-PI\n  2. Patient must have excisional biopsy or core biopsy done in order to be on protocol\n* Subjects must have clinically or radiographically evident measurable gross disease at either the primary tumor site or nodal stations.\n* Oropharyngeal Carcinoma (AJCC, 7th ed.) without evidence of distant metastasis based on FDG PET\u002FCT.\n* CT or MRI of the neck with and without contrast Note: A CT scan of neck and\u002For a PET\u002FCT performed for the purposes of radiation planning may serve as planning tools.\n* ECOG Performance Status of 0-2 or KPS ≥ 50\n* Age ≥ 18 Patients over 70yrs will be able to enroll in Cohort B only).\n* Adequate hematologic function within 30 days prior to registration, defined as follows:\n\n  1. White Blood Count (WBC) ≥ 2 K\u002FmcL\n  2. Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm3\n  3. Platelets ≥ 100,000 cells\u002Fmm3\n  4. Hemoglobin ≥ 8.0 g\u002Fdl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable\n* Adequate renal function within 30 days prior to registration, defined as follows:\n\n  1. Serum creatinine \\\u003C 1.5 mg\u002Fdl or creatinine clearance (CC) ≥ 50 ml\u002Fmin determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \\[(140 - age) x (wt in kg)\\] \\[(Serum Cr mg\u002Fdl) x (72)\\] CCr female = 0.85 x (CrCl male)\n\nNote: Patients who cannot tolerate cisplatin or carboplatin\u002F5FU based on clinical judgment will receive carboplatin and paclitaxel Paclitaxel can be substituted with Abraxane (Albumin-bound Paclitaxel).\n\n* Adequate hepatic function within 30 days prior to registration, defined as follows:\n\n  1. Bilirubin \\\u003C 2 mg\u002Fdl\n  2. AST or ALT \\\u003C 3 x the upper limit of normal\n\nNote: Exceptions can be made with PI and\u002For Co-Pi approval for patients to enroll on trial with a higher Bilirubin level such as Gilbert's Syndrome.\n\nNote: Patients who cannot tolerate cisplatin or carboplatin\u002F5FU based on clinical judgment will receive carboplatin and paclitaxel. Paclitaxel can be substituted with Abraxane (Albumin-bound Paclitaxel).\n\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential\n* The subject must provide study-specific informed consent prior to study entry\n* Subject able to undergo MRI scans except for major medical contraindications like presence of a pacemaker or approved by the PI or the CO-PI that the subject does not need to undergo MRI scans\n\nExclusion Criteria:\n\n* Subjects with prior head and neck radiation therapy\n* Subjects with simultaneous primary cancers outside of the oropharynx\n\n  a. Note: Exceptions can be made for patients with simultaneous primaries outside the oropharynx if determined by the PI\u002FCo-PI the patient can proceed with protocol activities.\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years to be 90% or greater\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable\n* Severe, active co-morbidity defined as follows: (exceptions can be made if approved by the PI and\u002For co-PI)\n\n  1. Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  2. Transmural myocardial infarction within the last 6 months\n  3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n  4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration\n  5. Hepatic Insufficiency resulting in clinical jaundice and\u002For coagulation defects",{"count":217,"type":20},121,[23],"The purpose of this study is to find out if lower doses of radiation may help reduce the side effects of radiation therapy in combination with standard-of-care chemotherapy in people with HPV-positive throat cancer. The chemotherapy drugs used in this study include cisplatin, carboplatin, and 5-fluorouracil (5- FU), paclitaxel and abraxane- (Albumin-bound Paclitaxel).",[200,221,222,167,26],"Throat Cancer","Oropharyngeal Carcinoma",[224,200,221,26,222,167,225,226,227],"HPV-Positive Throat Cancer","Radiation Therapy","22-215","Memorial Sloan Kettering Cancer Center","2026-04-22",{"date":230,"type":35},"2026-04-23",{"date":232,"type":35},"2022-08-04",{"date":234,"type":20},"2027-08-04",{"name":227,"class":42},7,{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":43},"100506931","multidimensional-and-multimodal-profiling-of-oropharyngeal-carcinoma-100506931","NCT05880797","Multidimensional and Multimodal Profiling of Oropharyngeal Carcinoma","Inclusion Criteria:\n\n* Patients diagnosed with oropharyngeal carcinoma or patients with cancer of the unknown primary that is HPV associated, or possibly deemed to be originating from the oropharynx.\n\nExclusion Criteria:\n\n* Not willing to sign consent",{"count":244,"type":20},1000,"The purpose of this study is to better understand the natural history of oropharyngeal carcinoma (OPC), with or without an association with the human papilloma virus (HPV). For this study, the investigators plan to collect blood from OPC patients prior to treatment and at six subsequent time points.",[222,26],"2026-04-09",{"date":249,"type":35},"2026-04-13",{"date":251,"type":35},"2023-07-07",{"date":253,"type":20},"2026-08",{"name":255,"class":42},"Stanford University",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":79,"sex":80,"minAge":17,"maxAge":106,"enrollmentInfo":263,"targetDuration":4,"studyType":21,"phases":265,"briefSummary":267,"conditions":268,"keywords":269,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":280},"100477356","phase-4-a-study-of-reduced-dosing-of-the-nonavalent-hpv-vaccine-in-women-living-with-hiv-100477356","NCT05495906","A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV","NOVA-HIV","Inclusion Criteria:\n\n* Living with HIV\n* Has a uterine cervix\n\nExclusion Criteria:\n\n* Unable to give fully informed consent\n* Pregnant or unwilling to avoid pregnancy during vaccination\n* Allergy to the vaccine or its components\n* Prior receipt of any HPV vaccine",{"count":264,"type":20},275,[266],"PHASE4","There are very little data on human papillomavirus (HPV) vaccination among the 18 million women living with HIV (WLWH) globally, who constitute a population most vulnerable to HPV and the resultant cervical cancer. Particularly, there are no data to date on reduced-dose schedules of nonavalent HPV (9vHPV) vaccination in WLWH and there are very little data on the 9vHPV vaccine in this population overall. It is critical to examine the 9vHPV vaccine in WLWH now because the quadrivalent HPV (4vHPV) vaccine has been discontinued. Additionally, in order to reach the World Health Organization's global goal of cervical cancer elimination, we must determine the role of various HPV prevention strategies in this important population including reduced vaccine dosing which can drastically increase the feasibility of HPV vaccination programs globally.\n\nThis randomized clinical trial will enrol WLWH aged 18-45 from across Canada who have not previously received an HPV vaccine. Participants will be randomized 1:1 to receive 3 doses of 9vHPV vaccine at the routine vaccine schedule of 0\u002F2\u002F6 months or 2 doses at an expanded schedule of 0\u002F6 months with a third dose at month 12 to adhere to current recommendations for WLWH. We will compare the immune response generated to two versus three doses of 9vHPV vaccine and will follow participants for 2 years to examine the immune response over time.\n\nThis study, which builds upon our team's prior work on HPV vaccination in WLWH, will determine whether two doses of 9vHPV vaccine can be used in WLWH instead of three, and will examine additional aspects of HPV vaccination in WLWH including the immune response to three doses, vaccine safety and efficacy, and attitudes towards self-collected HPV samples in this population. These data will inform global public health policy and programming and will inform the global strategy for cervical cancer elimination.",[200,26,195],[270],"HPV vaccination","2026-02-03",{"date":273,"type":35},"2026-02-05",{"date":275,"type":35},"2023-07-27",{"date":277,"type":20},"2028-01",{"name":279,"class":42},"University of British Columbia",10,{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":79,"sex":16,"minAge":288,"maxAge":106,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":4},"100576525","phase-4-managing-hepatitis-b-hep-b-and-human-papilloma-virus-hpv-related-cancers-and-mental-health-100576525","NCT06786429","Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers and Mental Health.","Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers Among Women of Childbearing Age, and Young Adults in Zimbabwe in the Context of Mental Health: a Multimodal, Multifaceted Approach.","Inclusion Criteria:\n\n* For the High school students' group:\n\nAll students aged 13 years and older, enrolled at the selected Mtshabezi and Matopo High Schools in the Gwanda and Matobo Rural Districts during the five-year period of the project are eligible to participate in the study.\n\nAbility to understand and respond to questions on the Youth Risk Behavior Scree questionnaire and PHQ-9 scale.\n\nRelevant history of HPV vaccine administration. Ability to obtain parental\u002Fguardian consent for participation.\n\n\\- For the women group: All women and young female adults thirteen to forty-five years old and requesting health services for prenatal, post-partum, family planning and other care during the five-year project period are eligible to participate.\n\nMust not have received Hep B and HPV vaccine in the past and have no known contraindications to either of these two vaccines.\n\nAre able to understand and respond to the PHQ-9 and Edinburgh Postnatal Depression scales.\n\nMust have a valid consent for participation in the study.\n\nExclusion Criteria:\n\n* males who are not enrolled in these participating High Schools.\n* children below the age of thirteen who are not enrolled in high schools and are not seeking prenatal, post-partum and family planning services at these selected health facilities during the project period.\n* Any eligible potential participant without a valid consent.\n* Any potential participant who is excluded by a doctor or midwife for a known contraindicating medical condition that can lead to potential harm to the participant or staff.\n\nAny potential participant who is unable to understand and respond to the questions being asked.\n\nParticipants with proof of prior vaccination will be excluded from this part of the study.","13 Years",{"count":290,"type":20},1800,[266],"Aim: The main goal of this observational study is to determine the prevalence of Human Papilloma Virus(HPV) infection, and Hepatitis B (Hep B) immunity amongst women of childbearing age 13 to 45 years) attending clinics at Mtshabezi Mission and Matobo clinic respectively; and assess behavioral risk factors of high school students at these catchment areas that can put them at risk for developing cancer of the cervix and liver.\n\nQuestion: Can screening for cancer, and vaccination against Hep B and HPV, and cognitive behavior intervention help in preventing related cancers amongst these groups of participants.",[294,26,295,296,297,298,299],"Hepatitis B","Gall Stones (& [Calculus - Gall Bladder])","Mental Health Issue","Cancer Liver","Cancer of Cervix","Depression, Anxiety","2026-01-17",{"date":302,"type":35},"2026-01-21",{"date":304,"type":20},"2026-08-30",{"date":306,"type":20},"2031-12-30",{"name":308,"class":42},"Eunice Dube",{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":79,"sex":80,"minAge":105,"maxAge":82,"enrollmentInfo":316,"targetDuration":4,"studyType":21,"phases":318,"briefSummary":319,"conditions":320,"keywords":324,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":338,"locationsCount":43},"100618785","popsci-chw4cervixhealth-100618785","NCT07336134","PopSci CHW4CervixHealth","Uptake of HPV Self-sampling in Underserved Minority Women Using a Community Health Worker Model: Comparison of Evalyn Brush and Copan Floqswab","Inclusion Criteria:\n\nPhase I:\n\n* Women aged 25-65 years\n* Scheduled for a Pap smear test appointment at Jefferson OBGYN Center City location\n* Willing and able to provide informed consent for participation in the study\n* Agree to perform an HPV self-collection collection procedure during the same visit\n* Have not undergone a hysterectomy (intact cervix required)\n\nPhase II:\n\nThis intervention targets under-screened minority individuals who must meet all the following inclusion criteria to be eligible to participate in the study:\n\n* Women aged 25-65 years\n* Who has not had a Pap smear in the past three to five years based on age of prior screening and type of screening. If under the age of 30, in the past 3 years and if over the age of 30, in the past 5 years. Participant will self-report normal pap smear and date.\n* Self-identify as Hispanic, Black\u002FAfrican or Black Caribbean, Chinese, Korean, or Vietnamese\n* Competent to give consent and provide signed and dated informed consent form in their preferred language.\n\nExclusion Criteria:\n\nPhase I:\n\n* Current pregnancy (self-reported or confirmed)\n* Previous participation in an HPV self-collection study within the past 12 months\n* Presence of visible vaginal or cervical infection or symptoms suggestive of a current genital tract infection\n* Inability to comply with study procedures or follow instructions (e.g., due to language barriers or cognitive impairments)\n\nPhase II:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Have a history of hysterectomy, cervical cancer\n* Self-report participation in a cervical cancer screening or other prevention study\n* Pregnant (self-reported)\n* Inability to provide informed consent",{"count":317,"type":20},120,[85],"Phase I: Validating self-collection kit by comparing their results with clinical Pap smear results in a cohort of 20 patients.\n\nPhase II: Evaluate the feasibility and acceptability of the CHW4CervicalHealth: Use of a self-collection kit to improve cervical health screening intervention aimed to promote HPV self-collection uptake among screening-eligible and under-screened ethnic minority women in the community.",[321,322,26,323],"Cervical Cancer","Hpv","HPV Infection",[325,326,327,328,329,330,331],"Copan FLOQswab","Evalyn® Brush","HPV self-collection","self-collection","community health workers","underscreened women","concordance","2026-01-09",{"date":334,"type":35},"2026-01-13",{"date":336,"type":35},"2025-10-22",{"date":93,"type":20},{"name":339,"class":42},"Thomas Jefferson University",{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":79,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":21,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":43},"100409402","educate-and-improve-underserved-populations-uptake-and-completion-of-the-hpv-vaccine-100409402","NCT04611022","Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccine","Intervention to Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccine Series","Inclusion Criteria:\n\n1. Be a Denver Health patient\\* 18-26 years old, who has not started or completed the HPV vaccine series (Vaccine completion for this age group is 3 doses).\n2. Be a parent of a Denver Health adolescent patient\\* aged 9-17 years old, who has not started or completed the HPV vaccine series. (Vaccine completion is 2 doses for 9-14-year-old, and 3 doses for 14-17-year old)\n3. English and\u002For Spanish Speaking\n4. Stated willingness to comply with all study procedures and be available for the duration of the study\n\n   * Denver Health patients will be identified from one of the following clinics; Denver Health Clinics Eastside Adult Clinic, Eastside Women's Care Clinic, Westside Adult Clinic, Westside Women's Care Clinic, Pavilion C: Women's Care Clinic, La Casa-Quigg Newton Family Health Center, Lowry Family Health Center, Montbello Family Health Center, Westwood Family Health Center, Parkhill Family Health Center, Webb Center For Primary Care, Pena Southwest Clinic\n\nExclusion Criteria:\n\n1. Individuals who do not meet eligibility criteria, including individuals who do not speak English or Spanish \\[at the discretion of the CHE or PN upon recruitment\\]\n2. Decisionally-challenged adults with cognitive or personality impairment or due to intoxication (alcohol or drugs) that might interfere with their ability to consent or participate in the study \\[at the discretion of the CHE or PN upon recruitment\\]\n3. Individuals from vulnerable populations (e.g., inmates, homeless, pregnant women, and those with auditory impairment \\[at the discretion of the CHE or PN upon recruitment\\]\n4. Individuals under the age of 18 years.",{"count":244,"type":20},[85],"The educational intervention to be delivered by the PN(Patient Navigator) consists of \"toolkit education materials\" developed by the National Cancer Institute (NCI) and a small media intervention (i.e., video) that our research team has developed. The NCI-produced toolkit education materials consist of Power Point presentations, flyers, and posters that contain information about HPV(Human Papilloma Virus), HPV-related cancers, and the importance of the HPV vaccine series for adolescents (9-17 years old) and young adults (18-26 year old) who are eligible for the vaccine.",[26],"2025-11-19",{"date":353,"type":35},"2025-11-25",{"date":355,"type":35},"2020-08-28",{"date":357,"type":20},"2028-02-01",{"name":359,"class":42},"University of Colorado, Denver",{"id":361,"slug":362,"hasResults":11,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":378,"locationsCount":381},"100610805","prevention-of-cervical-cancer-using-the-genotyping-screening-and-same-day-self-sampling-100610805","NCT07232355","Prevention of Cervical Cancer Using the Genotyping Screening and Same-day Self-sampling","PROGRESS: Prevention of Cervical Cancer Using the Genotyping Screening and Same-day Self-sampling","PROGRESS","Inclusion Criteria:\n\n* Presence of a cervix\n\nExclusion Criteria:\n\n* Pregnancy\n* Cervical cancer screening in the past 2 years\n* Prior diagnosis or treatment of cervical cancer\n* Inability to tolerate a speculum exam","64 Years",{"count":370,"type":20},5000,"In May 2018, the World Health Organization (WHO) launched a strategy to eliminate cervical cancer. While this strategy seeks to achieve coverage of 70% in disease testing and 90% in treatment by 2030, it is estimated that these goals will not be achieved by most low- and middle- income (LMICs) countries until 2120 under existing conditions. Presently, more than 90% of worldwide cervical cancer cases occur in LMICs. To accelerate this timeline, there is an urgent need for accurate, affordable and rapid testing that can facilitate same-day screening-and-treatment of cervical precancer. The AmpFire® human papillomavirus (HPV) test (Atila Biosystems, CA) has the potential to meet these needs. The test has been adapted to classify HPV positive women into four categories according to their risk for cervical cancer development based on the specific HPV type found during the test. Moreover, results can be delivered in less than 20 minutes for the highest risk HPV type, and less than an hour for the remaining HPV types. This is a potential game changer for countries where treating all HPV positive women is unfeasible. A combination of HPV test with other image-based triage strategies can further reduce overtreatment while reaching the most at-risk women. The goal of this project is to evaluate the performance and feasibility of an innovative same-day screening-and-treatment strategy in Honduras based on the AmpFire® HPV test combined with imaging triage using artificial intelligence via the Automated Visual Evaluation (AVE). Additionally, the investigators will evaluate the cost-effectiveness of the proposed approach vs. the current strategy based on visual inspection with acetic acid (VIA). The investigators believe that the AmpFire® test will have the potential to detect at least 90% of women with cervical precancer (performance). Similarly, the investigators anticipate that combining AmpFire® with AVE triage in a same-day screening-and-treatment strategy will be feasible and acceptable to patients and providers. The successful completion of this project will provide crucial data on the effectiveness of a self-sample, same-day screening-and-treatment approach with the potential to increase early detection while reducing loss to follow-up, ultimately resulting in increased adoption of this technology.",[26],"2025-11-17",{"date":351,"type":35},{"date":376,"type":35},"2023-08-24",{"date":205,"type":20},{"name":379,"class":380},"Atila Biosystems Inc.","INDUSTRY",4,{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":16,"minAge":389,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":21,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":43},"100461683","phase-2-candida-antigen-and-bivalent-hpv-vaccine-in-the-treatment-of-multiple-warts-100461683","NCT05291845","Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts","Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts: Monotherapy Versus Combined Therapy","Inclusion Criteria:\n\n* patients with multiple, recalcitrant, or non-recalcitrant common warts of different sites, sizes, duration, and with or without distant lesions will be enrolled in the study\n\nExclusion Criteria:\n\n* Pregnant female. Hypersensitivity to Candida antigen or bivalent HPV vaccine","9 Years",{"count":391,"type":20},162,[23],"To follow up the efficacy and safety of Candida antigen, bivalent HPV vaccine in treatment of common warts either mono or combined intralesional therapy",[395,26],"Warts","2025-06-09",{"date":398,"type":35},"2025-06-12",{"date":400,"type":35},"2022-04-03",{"date":402,"type":20},"2025-12-06",{"name":404,"class":405},"Zagazig University","OTHER_GOV",{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":21,"phases":416,"briefSummary":418,"conditions":419,"keywords":422,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":98},"100376181","phase-3-stereotactic-boost-and-short-course-radiation-therapy-for-oropharynx-cancer-100376181","NCT04178174","Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer","Stereotactic Boost and SHOrt-course Radiation Therapy for HPV-associated OroPharynx Cancer Trial: A Randomized Multicentric Phase III Trial","SHORT-OPC","Inclusion Criteria:\n\n* Age ≥18 years\n* Ability to provide written informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.\n* Positive for HPV by p16 immunohistochemistry (IHC) or HPV in-situ hybridization (ISH)\n* Clinical stage T1-3, N1 M0 (Stage I-II) as per AJCC 8th edition.\n* Primary tumor \\\u003C 30 cc\n* Planned for curative chemoradiation\n* For females of child-bearing age, a negative pregnancy test\n\nExclusion Criteria:\n\n* Clinical N3 classification, as per AJCC 8th edition\n* Clinically overt extranodal extension (ENE). As per AJCC 8th edition, clinically overt ENE is defined as invasion of the skin, infiltration of musculature\u002Ffixation to adjacent structures on clinical examination, cranial nerve, brachial plexus, sympathetic trunk or phrenic nerve invasion with dysfunction).\n* Previous irradiation of the head and neck region\n* Previous surgery of the HNC region (except for incisional or excisional biopsies)\n* Pregnancy or breastfeeding\n* Connective tissue disease\n* Any medical condition that could, in the opinion of the investigator, prevent follow-up after radiotherapy.\n* Non-Cisplatin concurrent chemotherapy\n* Prior induction chemotherapy",{"count":415,"type":20},360,[417],"PHASE3","This is a randomized clinical trial comparing the outcomes of short-course chemoradiation consisting in stereotactic boost to the gross tumor and de-esclalated chemoradiation to the elective neck in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation.",[420,421,26],"Head and Neck Cancer","Oropharynx Cancer",[423,424,60,425,426,427,428],"head and neck cander","Oropharynx cancer","Radiotherapy","Stereotactic body radiotherapy","Chemotherapy","De-intensification","2025-05-14",{"date":431,"type":35},"2025-05-18",{"date":433,"type":35},"2020-02-23",{"date":435,"type":20},"2029-12",{"name":437,"class":42},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":439,"slug":440,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":79,"sex":129,"minAge":17,"maxAge":446,"enrollmentInfo":447,"targetDuration":4,"studyType":21,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":458,"locationsCount":98},"100564105","phase-2-evaluating-gardasil-hpv-vaccine-humoral-and-cellular-immune-responses-in-people-with-and-without-hiv-100564105","NCT06624839","Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV","A PRe-pOsT Interventional Study Evaluating Gardasil Nine-valent Human Papilloma Virus (HPV) Vaccine Humoral and Cellular Immune Responses in People With or Without HIV","PROTECT","Inclusion Criteria:\n\n* 18 years old or older and 70 years old or younger\n* Able to provide informed consent\n* Denies history of prior HPV vaccination with Gardasil9 (receipt of HPV vaccination other than Gardasil9 such as the bivalent or the quadrivalent HPV vaccine will be allowed) or unsure of vaccination status and born before 2003\n* Born Male\n\nFor Test group: HIV-positive people born male with current or past exposure to androgen blockers or estrogen (BM-EABE)\n\n* Living with HIV\n* Current or past exposure to androgen blockers or estradiol\n\nFor Control group: HIV-negative Control\n\n* HIV negative\n* Either: Current or past exposure to androgen blockers or estradiol; no current or past exposure to androgen blockers or estradiol AND had sex with a person with a penis in the last year\n\nExclusion Criteria:\n\n* Younger than 18 years old or older than 70 years old.\n* Self-reported or documented history of nine-valent HPV vaccine or unsure of vaccination status and born after 2003.\n* Born female\n* History of hypersensitivity, including severe reactions to yeast or other component of the vaccine.\n* Any condition requiring systemic chemotherapy or immunomodulant affecting antibody responses (i.e., rituximab, ibrutinib etc.), intravenous or subcutaneous immunoglobulin supplementation, radiation therapy, or immunomodulatory treatment within the previous 6 months (presence of precancerous lesions is not exclusionary).","70 Years",{"count":317,"type":20},[23],"This is a phase 2, open-label study to assess the immunogenicity of the 9-valent human papillomavirus (HPV) recombinant vaccine (Gardasil9) in people born male with current or past exposure to androgen blockers or estrogen (BM-EABE). Investigators will enroll BM-EABE with HIV and HIV negative controls (BM-EABE or men who have sex with a person with a penis (MSPP)) and administer Gardasil9 at timepoints Day 0, Month 2, and Month 6. The immune response to the vaccine will be analyzed at Month 7 (1 month following the final vaccine dose).",[26,451,199],"Anal Dysplasia","2025-04-30",{"date":454,"type":35},"2025-05-04",{"date":456,"type":35},"2025-03-15",{"date":277,"type":20},{"name":459,"class":42},"University of Maryland, Baltimore",{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":80,"minAge":467,"maxAge":468,"enrollmentInfo":469,"targetDuration":4,"studyType":21,"phases":471,"briefSummary":472,"conditions":473,"keywords":475,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":98},"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":470,"type":20},180000,[85],"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.",[26,474,321],"Cervical Intraepithelial Neoplasia",[476,270,60,477],"Organized screening","Prevention","2025-03-18",{"date":480,"type":35},"2025-03-19",{"date":482,"type":35},"2020-11-16",{"date":484,"type":20},"2038-12-31",{"name":486,"class":42},"Karolinska Institutet",{"id":488,"slug":489,"hasResults":11,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":4,"eligibilityCriteria":493,"healthyVolunteers":79,"sex":80,"minAge":105,"maxAge":446,"enrollmentInfo":494,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":43},"100488483","vaginal-microbiome-and-hpv-pre-malignant-and-cervical-dysplasia-100488483","NCT05640700","Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia","Assessing Personalized Vaginal Microbiome Contributions to HPV-driven Pre-malignant and Malignant Cervical Cancer","Inclusion Criteria:\n\n* Age 25-70\n* Attended the clinic for a Pap smear or colposcopy\n\nExclusion Criteria:\n\n* Patient does not approve sample collection\n* Usage of antibiotics in the month prior to clinic visit\n* Usage of any vaginal preparation or medication in the week prior to sample collection (anti-fungal, spermicides, lubricant etc.)\n* Menstruation\n* Pregnancy",{"count":495,"type":20},90,"In this study, the investigators will prospectively collect, analyze and integrate information regarding vaginal microbiome composition and HPV presence in women with cervical pathologies (high-grade CIN and CC) and controls, to construct a large dataset from patients with pre-cancerous cervical lesions and healthy women, to evaluate the personalized contribution of the vaginal microbiome to the CIN-CC sequence.",[26,498,499,500],"Vaginal Flora Imbalance","Cancer Cervix Uterus","Cervical Dysplasia",{"date":480,"type":35},{"date":503,"type":35},"2022-11-09",{"date":505,"type":20},"2025-12-30",{"name":507,"class":42},"Hadassah Medical Organization",{"id":509,"slug":510,"hasResults":11,"nctId":511,"briefTitle":512,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":515,"conditions":516,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":43},"100569724","high-resolution-anuscopy-study-100569724","NCT06697964","High Resolution Anuscopy Study","Inclusion Criteria:\n\n* All patients who have undergone HRA and all future patients referred for HRA in UZ Brussel\n* 18 years or older\n* Understands and able to speak and write in French, Dutch or English\n\nExclusion Criteria:\n\n* None",{"count":108,"type":20},"The majority of anal squamous cell carcinomas (SCC) stem from infection with high-risk human papillomavirus (HPV). Anal SCC is rare among the general population but affects several populations disproportionately.\n\nHigh-risk groups are screened through anal swabs for anal cytology and detection of high risk human papillomavirus (HR HPV). HRA referral is recommended for individuals with abnormal cytology.\n\nHRA represents the only method to identify precancerous lesions of the anal canal, with only few specialists knowledgeable about it.\n\nAt UZ Brussel, the investigators collected a wealth of data about HPV infection and its association with anal pathology. By establishing a comprehensive study, the investigators can delve into this data with specific research questions, conducting valuable research to provide answers to pressing clinical questions and contribute to advancements in medical understanding and treatment.",[26,517],"Anal Squamous Cell Carcinoma","2025-02-14",{"date":520,"type":35},"2025-02-19",{"date":522,"type":35},"2024-08-08",{"date":524,"type":20},"2029-07",{"name":526,"class":42},"Universitair Ziekenhuis Brussel",{"id":528,"slug":529,"hasResults":11,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":11,"sex":80,"minAge":105,"maxAge":106,"enrollmentInfo":535,"targetDuration":4,"studyType":21,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":549},"100380386","phase-4-study-of-2lpapi-on-the-clearance-of-genital-hr-hpv-infections-100380386","NCT04232917","Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.","Randomized, Placebo-controlled, Double-blind Study to Evaluate 2LPAPI® Efficacy on the Clearance of Genital HR-HPV Infections.","PAPION","Inclusion Criteria:\n\n* Women 25-45 years,\n* Women of childbearing age under effective contraception,\n* Patient with last cytology less than 3 years and normal or not more than LSIL or CIN I at the histology,\n* Patient with current cytology presenting normal, ASC-US, AGUS, LSIL, ASC-H, AGC or LSIL+ASC-H results or current diagnosis of CIN I at the histology,\n* Patient with HR-HPV diagnosis at the current cervical collection,\n* Patient reporting a current stable sexual relationship (steady sexual partner during study duration),\n* Patient having faculties to understand and respect the constraints of the study,\n* Signature of the Informed Consent Form.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman,\n* Patient presenting HSIL diagnosis at the cytology or CIN II or CIN III diagnosis at the histology,\n* Patient having received HPV vaccination in the last month,\n* Patient previously subject to total hysterectomy,\n* Patient under immunotherapy (including immunosuppressive treatment) or micro-immunotherapy received during last previous 6 months,\n* Patient with known lactose intolerance,\n* Patient who participated in a clinical study in the previous 3-months' period,\n* Patient who is not sufficiently motivated to engage in a follow-up period of 12 months, or likely to travel or to move before the end of the study,\n* Patient with severe immunodeficiency disease requiring long term treatment (\\*) or under chemotherapy or radiotherapy,\n* Patient under listed homeopathic or phytotherapy treatment (see protocol),\n* Patient using or addicted to recreational drugs.\n\n(\\*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV\u002FAIDS, terminal cancer.",{"count":536,"type":20},284,[266],"Human papillomavirus (HPV) is a prevalent pathogen, the epidemiology of which has mostly been studied in the uterine cervix and the vagina.\n\nThe KCE Report 238Cs (2015) recommends \" HR-HPV-positive women should not be offered colposcopy immediately. Triage should be done using cytology for this purpose. If cytological abnormalities (ASCUS+) are found, immediate referral should follow for diagnosis and, where appropriate, treatment. If no abnormalities are observed in triage, the subject should be offered follow-up testing (cytology) at six months. \".\n\nThere is no treatment that is recommended during this lap time. The 2LPAPI® has been available for more than 20 years, and has received a marketing authorization in Belgium by the FAMHP. It is used as an immune regulator in the treatment of HR-HPV infections. Since 2LPAPI® has been made available, clinical observational data collected on treated patients have shown the beneficial effect on the clearance of HPV.\n\nThe purpose of this placebo-controlled trial is to evaluate the efficacy of 2LPAPI® on the clearance of genital HR-HPV infections.",[26],"2024-10-29",{"date":542,"type":35},"2024-10-31",{"date":544,"type":35},"2020-10-17",{"date":546,"type":20},"2027-10-30",{"name":548,"class":380},"Labo'Life",12,{"id":551,"slug":552,"hasResults":11,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":11,"sex":80,"minAge":105,"maxAge":368,"enrollmentInfo":558,"targetDuration":4,"studyType":21,"phases":559,"briefSummary":560,"conditions":561,"keywords":565,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":43},"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.",{"count":54,"type":20},[85],"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.",[562,563,26,564],"Uterine Cervical Neoplasm","Uterine Cervical Dysplasia","HPV-Related Cervical Carcinoma",[566,567,568,569,570,571,572],"biomarker","first-void urine","vaginal sample","screening","triage","self-sampling","prevention","2024-09-13",{"date":575,"type":35},"2024-09-19",{"date":577,"type":35},"2024-03-28",{"date":579,"type":20},"2037-02-28",{"name":581,"class":42},"Universiteit Antwerpen",{"id":583,"slug":584,"hasResults":11,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":11,"sex":80,"minAge":105,"maxAge":590,"enrollmentInfo":591,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":593,"conditions":594,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":43},"100558393","impact-of-human-papillomavirus-carriage-on-ivficsi-results-hpv-amp-100558393","NCT06550531","Impact of Human Papillomavirus Carriage on IVF\u002FICSI Results (HPV AMP)","Impact of Human Papillomavirus Carriage on IVF\u002FICSI Results at Brest University Hospital","HPV-AMP","Inclusion Criteria:\n\n* all etiology of infertility AMH \\> ou = à 1.1 ng\u002Fml First ou second protocol of IVF between 25 years and 37 years and 11 months\n\nExclusion Criteria:\n\nAge \\\u003C 25 y Age \\> ou = 38 y AMH \\\u003C 1.1 ng\u002Fml patient under juridic protection rejection of participation","38 Years",{"count":592,"type":20},618,"The prevalence of the papilloma virus in the general population is 12%. This virus is known to impair male fertility but its impact on female infertility remains uncertain. This is a public health problem since there is a vaccination protocol. Demonstrating the impact of the human papillomavirus on fertility would be an argument in favor of vaccination.",[26,595],"Infertility, Female","2024-08-09",{"date":598,"type":35},"2024-08-13",{"date":600,"type":35},"2022-02-04",{"date":602,"type":20},"2026-02-04",{"name":604,"class":42},"University Hospital, Brest",{"id":606,"slug":607,"hasResults":11,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":21,"phases":614,"briefSummary":615,"conditions":616,"keywords":623,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":4},"100484019","phase-1-autologous-t-cells-targeting-hpv16-hpv18--survivin-in-patients-with-rr-hpv-related-oropharyngeal-cancers-100484019","NCT05582590","Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R\u002FR HPV-related Oropharyngeal Cancers","A Phase 1 Open-Label Dose-Escalation Study of the Safety of Adoptively Transferred Autologous CD8+ T Lymphocytes Targeting HPV-16 E6\u002FE7, HPV-18 E6\u002FE7 and Survivin in Patients With Relapsed or Refractory HPV-related Oropharyngeal Cancers","Inclusion Criteria:\n\n1. The patient will be typed for HLA-A\\*0201 expression as determined by high resolution sequence-based typing method. If documented HLA results are available from a previous test, the patient can be enrolled using these results after review and approval by the sponsor.\n2. Patients with cytologically or histologically confirmed locally advanced or metastatic HPV related oropharyngeal cancers with confirmed detection of HPV-16 and\u002For HPV-18.\n3. Patients with HPV-related oropharyngeal cancers who have received at least 1 prior line of standard-of-care (SOC) treatment (for example, per the current NCCN Guidelines for Patients with Oropharyngeal Cancer) consisting of systemic immunotherapy and\u002For chemotherapeutic treatment.\n\n   1. The last dose of cytotoxic chemotherapy and\u002For steroids must be administered at least 28 days prior to the leukapheresis procedure.\n   2. Any adverse event(s) that the patient may have experienced from prior therapy must have resolved to ≤ Grade 1 according to NCI CTCAE version 5.0.\n4. Measurable disease per RECIST v1.1 criteria (at least 1 lesion that can be measured accurately in at least 1 dimension with the longest diameter ≥ 10 mm \\[MRI or CT scan sliced thickness ≤ 5 mm\\]).\n5. Pulse oximetry ≥ 92% on room air.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Life expectancy of at least 3 months.\n8. Be willing to comply with the study schedule and all other protocol requirements.\n9. Women of childbearing potential (WOCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have 2 negative pregnancy tests prior to treatment. All sexually active WOCBP and all sexually active male patients must agree to use highly effective methods of birth control throughout the study.\n10. Ability of the patient to understand and willingness to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. A diagnosis of other malignancies if the malignancy has required therapy within the last 3 years or is not in complete remission. Exceptions are non-metastatic basal cell or squamous cell carcinomas of the skin or prostate cancer that does not require treatment. Patients taking adjuvant hormonal therapy for definitively treated cancers (e.g., breast cancer, prostate cancer) are eligible.\n2. Major surgery within 28 days prior to the first study drug administration (minimally invasive procedures, such as diagnostic biopsies, are permitted).\n3. Known central nervous system involvement.\n4. Treatment with an allogeneic hematopoietic stem cell transplantation.\n5. Treatment with any investigational agent(s) at the time of informed consent.\n6. Left ventricular ejection fraction (LVEF) \\\u003C 45%, congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.\n7. The following hematological laboratory results at Screening (these results must be independent of blood product or hematopoietic growth factor support):\n\n   1. Hemoglobin \\\u003C 9.0 g\u002FdL.\n   2. Platelet count \\\u003C 100,000\u002FμL.\n   3. Absolute neutrophil count (ANC) \\\u003C 1000\u002F μL.\n8. The following chemistry laboratory results at Screening:\n\n   1. Serum creatinine ≥ 1.5 mg\u002FdL or estimated glomerular filtration rate (eGFR) ≤ 50 mL\u002Fmin\u002F1.73 m\\^2.\n   2. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3x the upper limit of normal (ULN) or serum total bilirubin \\> 2 mg\u002FdL (except for patients in whom hyperbilirubinemia is attributed to Gilbert's Syndrome).\n9. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) \\> 1.5x ULN within 1 week prior to the start of lymphodepletion chemotherapy, unless on a stable dose of an anticoagulant.\n10. Are pregnant or breastfeeding.\n11. Vaccination with any live virus vaccine is not permitted prior to the initiation of study treatment.\n\n    1. Inactivated annual influenza vaccination is allowed.\n    2. Vaccines such as COVID-19 vaccine, e.g., SARS-CoV-2 vaccine \\> 7 days before administration is acceptable. For vaccines requiring more than 1 dose, the full regimen should be completed prior to Cycle 1 Day 1.\n12. Active bacterial, viral, or fungal infection within 72 hours of the start of lymphodepletion chemotherapy; patients with ongoing use of prophylactic antibiotics, antifungal agents, or antiviral agents remain eligible as long as there is no evidence of active infection.\n13. Have human immunodeficiency virus (HIV) active infection as indicated by positive HIV polymerase chain reaction (PCR) test, human T-cell leukemia virus type 1 infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or are at risk for HBV reactivation (at risk for HBV reactivation is defined as being hepatitis B surface antigen \\[HbsAg\\] positive, or anti-HBe-antibody positive), or are positive for HBV DNA. HCV ribonucleic acid (RNA) must be undetectable by laboratory test.\n14. Any condition including the presence of laboratory abnormalities, that places the patient at an unacceptable risk if the patient was to participate in the study.\n15. Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).\n\n    Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted.\n16. Patients who experienced the following immune checkpoint inhibitor-related AEs even if the AE resolved to ≤ Grade 1 or baseline:\n\n    1. ≥ Grade 3 ocular AE\n    2. Changes in liver function tests that met the criteria for Hy's Law (\\> 3× ULN of either ALT\u002FAST with concurrent \\> 2× ULN of total bilirubin (total and direct) and without alternate etiology)\n    3. ≥ Grade 3 neurologic toxicity\n    4. ≥ Grade 3 colitis\n    5. ≥ Grade 3 renal toxicity",{"count":613,"type":20},36,[56],"This is a multicenter, open-label, Phase I, first-in-human trial to characterize the safety and clinical activity of an antigen-specific CD8+ T-cell product in patients with relapsed or refractory locally advanced or metastatic HPV-related oropharyngeal cancers. Patients must have received at least one prior standard treatment regimen consisting of systemic immunotherapy and\u002For chemotherapy. The investigative agent is an autologous adoptive T-cell product derived from the patient's endogenous cytolytic T cells that are directed toward HPV-16 E6\u002FE7, HPV-18 E6\u002FE7 antigens, and a tumor-associated antigen (Survivin) by ex vivo exposure to an artificial antigen presenting cell to which HLA-A2 antigen-peptides have been fit within the pocket of an MHC class 1 molecule. Patients must express HLA-A\\*0201.",[167,26,420,136,171,617,618,619,620,621,622],"Oropharyngeal Cancer, Metastatic","Head and Neck Cancer Metastatic","HPV-Related Squamous Cell Carcinoma","HPV-Related Mucosal Head and Neck Squamous Cell Carcinoma","Relapsed Oropharyngeal SCC","Refractory Oropharyngeal Squamous Cell Carcinoma",[624,625,626,627,628,629,630,631],"relapsed or refractory HPV-related oropharyngeal cancer","human papilloma virus-related cancer","HPV-related head and neck cancer","HPV-related oropharyngeal cancer","cell therapy","adoptive cell therapy","NEXI-003","Head and neck cancer","2024-01-12",{"date":634,"type":35},"2024-01-16",{"date":636,"type":20},"2025-03-31",{"date":638,"type":20},"2027-08-25",{"name":640,"class":380},"NexImmune Inc.",{"id":642,"slug":643,"hasResults":11,"nctId":644,"briefTitle":645,"officialTitle":645,"acronym":646,"eligibilityCriteria":647,"healthyVolunteers":11,"sex":80,"minAge":17,"maxAge":4,"enrollmentInfo":648,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":650,"conditions":651,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":43},"100482751","anal-follow-up-of-patients-with-a-gynecological-history-of-high-grade-lesion-and-more-induced-hpv-100482751","NCT05566106","Anal Follow-up of Patients With a Gynecological History of High-grade Lesion and More Induced HPV","Cohorte_HPV","Inclusion Criteria:\n\n* Patient whose age ≥ 18 years\n* Patient with a high-grade or higher HPV-induced gynecological lesion\n* Patient participating in the proctology follow-up protocol\n* French-speaking patient\n\nExclusion Criteria:\n\n* Patient with a history of induced high-grade anal HPV lesion and above\n* Patient under guardianship or curatorship\n* Patient deprived of liberty\n* Patient under court protection\n* Patient objecting to the use of his\u002Fher data for this research",{"count":649,"type":20},1500,"Human Papillomavirus (HPV) infection is the most common sexually transmitted infection in the world. It is currently estimated that 4.5% of all cancers worldwide are attributable to HPV, representing 630,000 new cases per year. HPV is responsible for more than 98% of pre-cancerous and cancerous lesions of the cervix and vagina and 88% of anal cancers.\n\nAlthough prevention of HPV infection has been available since 2007, there are approximately 3000 new cases of cervical cancer in France each year. Women benefit from organized screening for cervical cancer.\n\nHPV is also responsible for anal cancer in more than 90% of cases, mostly caused by HPV 16\u002F18. Its incidence is lower with 1162 cases in women in 2018 but is increasing strongly (+88% in women since 1990).\n\nAs with cervical cancer, there are precursors to anal cancer: high-grade intraepithelial lesions. Early diagnosis of these lesions could potentially reduce the incidence of anal cancer, but there are still few data in the literature. The prevalence of anal carriage in patients with a history of cervical dysplasia or cervical cancer is estimated in studies to be 20% with a risk of high grade anal lesions of 8%.\n\nThe relative risk of developing anal cancer in women with a history of high-grade cervical lesions is about 5 per 100,000, 15 per 100,000 for those with a history of cervical cancer, and 42 and 48 per 100,000 respectively for women with HPV-induced pre-cancer and cancerous lesions of the vulva.\n\nThe different means of cervico-vaginal screening: screening samples: HPV test, cytology, some biomarkers: double labelling p16\u002Fki67, E6-E7 mRNA and clinical examination with or without colposcopy (examination of the cervix with a magnifying glass) are used at the gynecological level but also at the anal level with as examination: simple anuscopy and high resolution anuscopy. Some scientific societies have established surveillance algorithms for certain risk groups, but there are no clinical practice recommendations yet for women with a history of gynecological HPV-induced lesions.\n\nA proctology follow-up protocol for at-risk patients is proposed to patients based on cervico-vaginal surveillance recommendations and data in the literature, pending clinical practice guidelines. The frequency of these examinations depends on the patient's age and the existence of other risk factors for the development of anal HPV lesions. Depending on these elements, follow-up is proposed every 3 years, 5 years, or annually.\n\nThe objective of this work is therefore to propose proctological surveillance to this population considered at risk, according to age, smear results and HPV test.",[26],"2022-10-04",{"date":654,"type":35},"2022-10-06",{"date":656,"type":35},"2022-09-22",{"date":658,"type":20},"2032-12-31",{"name":660,"class":42},"Fondation Hôpital Saint-Joseph"]