[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441268":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":25,"responsibleParty":46,"collaborators":10,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":10,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":10,"studyType":61,"phases":10,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Biological relatives without HPV",null,"Biological relatives, household contacts, and\u002For sexual partners without current HPV disease serving as controls to be compared with those from affected participants for evaluation of the differences between people with HPV and without.",{"label":13,"type":10,"description":14,"interventionNames":10},"Participants with HPV","Patients with recurrent HPV related diseases refractory to standard-of-care medical or surgical interventions.",[16],{"name":17,"affiliation":18,"role":19},"Andrea Lisco, M.D.","National Institute of Allergy and Infectious Diseases (NIAID)","PRINCIPAL_INVESTIGATOR",[21],{"name":17,"role":22,"phone":23,"phoneExt":10,"email":24},"CONTACT","(301) 761-7122","andrea.lisco@nih.gov",[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-77.10026,38.98067,{"lat":38,"lon":37},[41],{"name":42,"role":22,"phone":43,"phoneExt":44,"email":45},"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)","800-411-1222","TTY8664111010","prpl@cc.nih.gov",{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100441268","natural-history-epidemiology-and-pathogenesis-of-severe-hpv-related-diseases-neptune-100441268",false,"NCT05026138","Natural History, Epidemiology and Pathogenesis of Severe HPV-Related Diseases (Neptune)","* INCLUSION CRITERIA:\n\nInclusion Criteria for All Participants\n\n1. Aged \\>=3 years (except for household contacts and sexual partners of participants with HPV-related diseases, who must be aged 18 years and older).\n2. Able to provide informed consent or, if younger than 18, be accompanied by a parent(s)\u002Flegal guardian(s) who is able to provide informed consent.\n3. Willing to allow genetic testing on their collected biological samples.\n\nAdditional Inclusion Criteria for Participants with HPV-related Diseases\n\nHas severe, disseminated, recurrent, and treatment-refractory HPV infection, defined as one or more of the following confirmed by medical record review or participant health history:\n\n1. In participants without known primary or acquired immunodeficiency:\n\n   1. Multiple skin warts (\\>=5) recurrent\\* or refractory to standard-of-care interventions (eg, topical imiquimod, acetylsalicylic acid, cryotherapy, cantharidin, podophyllotoxin, bleomycin, cauterization, cidofovir, fluorouracil).\n   2. Concomitant skin warts (irrespective to recurrence or treatment response) AND any historical or current clinical and\u002For histologic or cytologic evidence of mucosal HPV-related diseases (oral, nasal, laryngeal, vaginal, anal, penile, or cervical).\n   3. Mucosal condyloma or other HPV-related diseases that are recurrent\\* or refractory to standard-of-care interventions.\n   4. Historical evidence of mucosal condyloma or any HPV-related diseases occurring irrespective of response to standard-of-care interventions and involving more than one mucosal site.\n2. In participants with known primary or acquired immunological defect (including idiopathic CD4 lymphopenia, immunosuppressive treatment, or HIV\u002FAIDS):\n\n   a. Any skin OR mucosal HPV-related diseases\n3. In any participant:\n\n   1. Recurrent invasive skin or mucosal HPV-related squamous cell carcinoma (HPV-SCC).\n   2. Historical or current histologic evidence of invasive HPV-SCC of any mucosal site in subjects with family history of HPV-SCC in 1 or more family members.\n\n      * The lack of complete response to 2 or more interventions is defined as treatment-refractory disease in the protocol, while the reappearance of a skin or mucosal lesion after complete resolution is defined as recurrence.\n\nAdditional Inclusion Criteria for Controls\n\n1\\. Biological relative, household contact, or sexual partner of the index participant (with HPV-related diseases) who meets one of the following criteria:\n\n1. does not have any historical or current clinical and\u002For histologic or cytologic evidence of skin or mucosal HPV-related diseases, or\n2. has historical or current clinical and\u002For histologic or cytologic evidence of skin or mucosal HPV-related diseases but does not meet the criteria to be enrolled in this study as a participant with HPV-related disease.\n\nEXCLUSION CRITERIA:\n\nIndividuals meeting any of the following criteria will be excluded from study participation:\n\n1. Laboratory abnormalities contraindicating research evaluations and procedures in patients without previous history of cytopenias: neutropenia (absolute neutrophil count \\\u003C500 cells\u002FmicroL) or thrombocytopenia (platelets \\\u003C10,000\u002FmicroL). Medical record review may be used to for determining eligibility if the laboratory tests were collected \\\u003C= 90 days prior to the screening visit.\n2. Inability to reliably keep research appointments and\u002For adhere to research procedures.\n3. Any condition that, in the opinion of the investigator, contraindicates participation in this study.\n\nAdditional Exclusion Criteria for Controls\n\n1\\. Has HPV-related disease that may indicate enrollment as an affected participant rather than as a healthy biological relative, household contact, or sexual partner.\n\nCo-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.",true,"ALL","3 Years","100 Years",{"count":59,"type":60},850,"ESTIMATED","OBSERVATIONAL","Background:\n\nMost symptoms of human papillomaviruses (HPV) infection, do not cause serious health problems, but some do. As HPV can cause uncontrolled growth of infected cells, some people can develop benign skin lesions, larger warts, genital lesions, tumors or cysts that do not respond to treatment. Researchers want to learn why.\n\nObjective:\n\nTo better understand why some people are more likely than others to get sick from HPV infection, and why medicine or surgery is not always effective.\n\nEligibility:\n\nPeople aged 3 years and older who have had multiple outbreaks of HPV-related warts and\u002For lesions that do not respond to treatment. Healthy relatives are also needed.\n\nDesign:\n\nParticipants will be screened with a medical history, physical exam, and blood tests.\n\nParticipants may have study visits as an outpatient or an inpatient (admitted overnight to the NIH hospital) and be followed over several years by our doctors and researchers at the NIH.\n\nParticipants may have a cervical and\u002For anal Pap test. They may give samples of semen, cervicovaginal secretions, urine, saliva, or stool. Small pieces of skin, the inside of the cheek, and\u002For the gums may be collected with a punch or scrape biopsy to understand how HPV affect the growth of cells.\n\nMucus and skin may be collected by rubbing the area with a cotton swab. Collection areas may include the inside the mouth, nostrils, skin, genitals, and\u002For in or around the anus.\n\nBiopsies may be collected. If participants need to have a biopsy as part of medical care, then we may ask if extra samples can be collected for research. Biopsies we may collect are bone marrow, lymph node, genitals, or in or around the anus.\n\nParticipants may have leukapheresis. Blood is taken from a needle placed in one arm. A machine separates out the white blood cells. The rest of the blood is returned through a needle in their other arm.\n\nSamples may be used for genetic tests and\u002For to make special cells called induced pluripotent stem cells.\n\nParticipants may have follow-up visits once a year for 10 years.\n\nBenefits:\n\nWe are not testing new HPV treatments in this study and you might not benefit from participating. However, we may learn new information about your condition that we will share with you and your doctor. We may make recommendations for your medical care based on current accepted treatment.\n\nWhat we learn from you and other participants in this study might help other people. We hope we can use this information to develop new treatments and therapies in the future....",[64],"Human Papillomavirus",[66,67,68,69,70,71],"Mucosal Disease","Immunocompromised","Genetic Defects","Infection","Neoplasia","Natural History","2026-04-10",{"date":74,"type":75},"2026-04-13","ACTUAL",{"date":77,"type":75},"2021-11-17",{"date":79,"type":60},"2047-03-31",{"name":18,"class":6},1]