Natural History, Epidemiology and Pathogenesis of Severe HPV-Related Diseases (Neptune)

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT05026138
Status
Recruiting
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Conditions

  • Human Papillomavirus

Eligibility Criteria

Sex
ALL
Age
3 Years - 100 Years
Healthy Volunteers
Accepted

Study Details

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....

Key Dates

Start date
Nov 17, 2021
Status verified
Apr 2026
Primary completion
Mar 31, 2047
Completion
Mar 31, 2047

Study Design

Enrollment
850 participants (estimated)

Arms

  • Arm: Biological relatives without HPV
    Biological relatives, household contacts, and/or 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.
  • Arm: Participants with HPV
    Patients with recurrent HPV related diseases refractory to standard-of-care medical or surgical interventions.

Primary Outcome Measure

Identify novel immunologic and/or genetic determinants of the susceptibility to severe disseminated, recurrent, and treatment-refractory HPV-related diseases. [ Time Frame: Throughout the study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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