Background:
Most 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.
Objective:
To 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.
Eligibility:
People aged 3 years and older who have had multiple outbreaks of HPV-related warts and/or lesions that do not respond to treatment. Healthy relatives are also needed.
Design:
Participants will be screened with a medical history, physical exam, and blood tests.
Participants 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.
Participants may have a cervical and/or 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/or the gums may be collected with a punch or scrape biopsy to understand how HPV affect the growth of cells.
Mucus 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/or in or around the anus.
Biopsies 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.
Participants 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.
Samples may be used for genetic tests and/or to make special cells called induced pluripotent stem cells.
Participants may have follow-up visits once a year for 10 years.
Benefits:
We 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.
What 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....
Aged >=3 years (except for household contacts and sexual partners of participants with HPV-related diseases, who must be aged 18 years and older).
Able to provide informed consent or, if younger than 18, be accompanied by a parent(s)/legal guardian(s) who is able to provide informed consent.
Willing to allow genetic testing on their collected biological samples.
Multiple skin warts (>=5) recurrent* or refractory to standard-of-care interventions (eg, topical imiquimod, acetylsalicylic acid, cryotherapy, cantharidin, podophyllotoxin, bleomycin, cauterization, cidofovir, fluorouracil).
Laboratory abnormalities contraindicating research evaluations and procedures in patients without previous history of cytopenias: neutropenia (absolute neutrophil count <500 cells/microL) or thrombocytopenia (platelets <10,000/microL). Medical record review may be used to for determining eligibility if the laboratory tests were collected <= 90 days prior to the screening visit.
Inability to reliably keep research appointments and/or adhere to research procedures.
Any condition that, in the opinion of the investigator, contraindicates participation in this study.
Participants will have HPV infection with severe, disseminated, recurrent, and treatment-refractory HPV related skin and mucosal disease. Healthy biological relatives, household contacts, and/or sexual partners will also be recruited to serve as controls for research tests.
Cohort
Prospective
Not listed
Identify novel immunologic and/or genetic determinants of the susceptibility to severe disseminated, recurrent, and treatment-refractory HPV-related diseases.
To define the clinical, immunologic, and genetic bases of severe disseminated, recurrent, and treatment-refractory HPV-related skin and mucosal disease.
Identify virologic, clinical, and immunologic predictors of progressive HPV-related diseases
Identify novel genetic defects associated with severe HPV related diseases.
Define the cellular and functional components involved in control or lack thereof of HPV infection in different cutaneous and mucosal surfaces
Define the natural history of HPV infections on skin and mucosal tissue in immunocompromised hosts; Define the epidemiology of skin and mucosal HPV variants in immunocompromised hosts by next-generation sequencing; Define the distribution of immune cells in skin and mucosal surfaces of patients with severe HPV-related diseases and immunologic correlates of HPV-disease progression.
Click on the lead sponsor to view all of their trials.
