NCT03644563Active, not recruiting
Men and Women Offering Understanding of Throat HPV
Impacting the Oral HPV Continuum: MOUTH Study (Men and Women Offering Understanding of Throat HPV)
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 21 Aug 2018
- Start date
- 3 Apr 2017
- Primary completion date
- 12 Aug 2026
- Lead sponsor
- Johns Hopkins University
- Diseases
- Head and neck cancer
- NCT number
- NCT03644563
What you commit to
- Study type: Observational
- Planned participants: 1500
- From 3 Apr 2017 to the primary completion date, 12 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent.
- History of head and neck cancer
- Participants in the Phase 2 Follow-Up
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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 from a family member or the study coordinator, this individual may still enroll and receive this assistance to ensure they fully hear and understand everything being asked.
- Unable to complete annual follow up visits
Who the study is looking for
- 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.
- Oncogenic oral HPV infection and/or HPV serum oncogenic antibodies detected in phase 1
- Willingness to complete annual follow up visits
Criteria the registry did not label
- Participants in the Phase 1 Screening
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.