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

Recruiting now

Conditions studied: Human Papillomavirus

In brief

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 facts

Study ID

NCT05026138

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

850

Starts

2021-11-17

Expected to finish

2047-03-31

Last updated by the study team

2026-07-06

Who can join

Age: 3 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Individuals meeting any of the following criteria will be excluded from study participation:
• 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.
• Additional Exclusion Criteria for Controls
• Has HPV-related disease that may indicate enrollment as an affected participant rather than as a healthy biological relative, household contact, or sexual partner.
• Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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