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NCT05026138 · ClinicalTrials.gov registry record
Natural History, Epidemiology and Pathogenesis of Severe HPV-Related Diseases (Neptune)
A clinical trial of Human Papilloma Virus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- 850
- Enrollment target
- 1
- Study location
NCT05026138: Recruiting study of Human Papilloma Virus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05026138 is a study of Human Papilloma Virus that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 850 participants, below the 8,420-participant average among 39 other Human Papilloma Virus trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05026138, a study of Human Papilloma Virus, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- 850 participants
- Enrollment target
- 1
- Study location
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. P
Primary Outcome
To define the clinical, immunologic, and genetic bases of severe disseminated, recurrent, and treatment-refractory HPV-related skin and mucosal disease.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 850 participants |
| Start Date | 2021-11-17 |
| Est. Completion | 2047-03-31 |
What NCT05026138 shows while recruiting
NCT05026138 is an observational study that tracks outcomes without assigning an intervention. The registered 850 participants enrollment target is mid-sized for trials with a published cap, below the 8,420-participant average among 39 other Human Papilloma Virus trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Human Papilloma Virus appearing as the primary indexed condition, and to 0 interventions.
NCT05026138 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05026138 about?
NCT05026138 is a clinical study titled "Natural History, Epidemiology and Pathogenesis of Severe HPV-Related Diseases (Neptune)". 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 treatmen...
What is the current status of trial NCT05026138?
This trial is currently recruiting. The enrollment target is 850 participants. The study started on 2021-11-17. Estimated completion is 2047-03-31.
What conditions does trial NCT05026138 study?
This clinical trial studies the following conditions: Human Papilloma Virus.
Who is sponsoring clinical trial NCT05026138?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05026138 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05026138's enrollment target sits among peer trials
850 11th of 39 higher than 29 of 39 other Human Papilloma Virus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Papilloma Virus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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