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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03644563). StuddyBuddy aggregates publicly available trial information.