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

NCT05026138 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 850

Last updated 2026-04-13

No results posted yet for this study

Summary

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....

Conditions

  • Human Papillomavirus

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Andrea Lisco, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
3 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-17
Primary Completion
2047-03-31
Completion
2047-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05026138 on ClinicalTrials.gov