NCT05026138

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

Recruiting now Last updated 13 April 2026

What this trial tests

trial in Human Papillomavirus in 850 participants. Currently enrolling.

Timeline

17 November 2021

Primary endpoint
31 March 2047

31 March 2047

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	850
Start date	17 November 2021
Primary completion	31 March 2047
Estimated completion	31 March 2047
Sites	1 location across United States

Conditions studied

• Human Papillomavirus — all drugs for Human Papillomavirus →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 3 to 100, any sex, with Human Papillomavirus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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....

Publications & conference data

No peer-reviewed publications indexed yet for this trial.