Active — Not RecruitingNot Applicable

Men and Women Offering Understanding of Throat HPV

United States1,500 participantsStarted 2017-04-03

Plain-language summary

This study will screen people for oncogenic oral Human Papillomavirus (HPV) infection and antibodies to form a cohort of people who may be at increased risk of HPV-oropharyngeal cancer (HPV-OPC). The investigators will follow these individuals prospectively to evaluate oncogenic oral HPV persistence, risk factors, and biomarkers for persistence.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Participants in the Phase 1 Screening Inclusion criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * 18 and older (enrollment at most sites will be restricted to 30 and older since this demographic has the highest prevalence of infection; however, individuals and/or partners of someone with an HPV-related cancer, for example, are at increased risk so will be enrolled in the larger age range). * Willing to be contacted to arrange follow-up visits, if determined to be eligible for phase 2 * Ability to understand and the willingness to sign a written informed consent document In addition, individuals must meet at least one of the following criteria: * Male, aged 30 and older, with 2 or more lifetime oral sex * History of anal or genital dysplasia or cancer * Partners of someone with an HPV-related cancer (HPV-positive OPC, anal cancer or genital cancer) * Known oncogenic HPV-positive biomarker from prior studies or testing, regardless of number of partners. Exclusion criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent. * Participants who do not speak English cannot enroll because the consent and study survey are only available in English. However, if there is a hearing, literacy or minor fluency issue and the participant requests assistance fr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Oncogenic oral HPV infection present or absent in oral rinse sample

Timeframe: Baseline to end of four year follow-up and data abstraction/linkage.

Trial details

NCT IDNCT03644563

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09

View on ClinicalTrials.gov More Oropharyngeal Cancer trials