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Active Not Recruiting
NCT03644563
Men and Women Offering Understanding of Throat HPV
Conditions: Oropharyngeal Cancer, Human Papilloma Virus
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 1500
Sponsor: Johns Hopkins University
Location: Johns Hopkins Hospital Baltimore Maryland
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.
Eligibility Criteria
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 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.
* History of head and neck cancer
Participants in the Phase 2 Follow-Up
Inclusion criteria:
* Oncogenic oral HPV infection and/or HPV serum oncogenic antibodies detected in phase 1
* Willingness to complete annual follow up visits
Exclusion criteria:
• Unable to complete annual follow up visits
Source: ClinicalTrials.gov (NCT03644563). StuddyBuddy aggregates publicly available trial information.