An observational study in Oropharyngeal Cancer and Human Papilloma Virus, sponsored by Johns Hopkins University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Johns Hopkins University · Observational
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.
This study will provide one of the first estimates of long-term oral HPV natural history, and the effect of biologic and behavioral risk factors, including HIV, on this natural history. Phase 1 of the study will screen approximately 1500 people for oncogenic oral HPV biomarkers. Phase 2 of the study will follow only those subjects with oncogenic oral HPV infection and/or HPV serum oncogene antibodies from Phase 1 (and those previously identified as having oncogenic oral HPV infection in a previous study) with annual follow-up for oncogenic oral HPV persistence.
Understanding persistent oncogenic oral HPV infection is the focus of this study. Understanding which factors drive oral HPV infection to become persistent or progress to malignancy is critical to determine who is at high risk for oropharyngeal cancer and may benefit from screening and prevention. It is presumed that persistent oncogenic oral HPV infections are necessary for progression to HPV-OPC.
The study is led by Dr. Amber D'Souza and Dr Carole Fakhry (Johns Hopkins) and participants are being enrolled in Baltimore MD (Johns Hopkins) and in New York (Mt. Sinai).
369 studies on the registry are indexed under Oropharyngeal Neoplasms; 103 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 137 across 74 observational studies indexed under Oropharyngeal Neoplasms.
Browse Oropharyngeal Neoplasms studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Target sample size: 1325 (phase 1), \~250 (phase 2) Inclusion of women and minorities: Primary enrollment is restricted to men, given their higher risk of infection (see eligibility criteria). However, the investigators expect to enroll women with cervical dysplasia and partners of patients with HPV-related cancer (\~125 expected women enrollees). Enrollment is across many different sources (geographically, and by clinic type), and is inclusive of diverse racial and ethnic backgrounds. Enrollment is not stratified by race but the investigators expect to enroll at least 175 minorities in the study.
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:
In addition, individuals must meet at least one of the following criteria:
Exclusion criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Participants in the Phase 2 Follow-Up
Inclusion criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Those subjects with oncogenic oral HPV infection and/or HPV oncogene serum antibodies from screening.
Oncogenic oral HPV infection present or absent in oral rinse sample
To explore the effects of biologic (microbiome, oral immune response, biologic sex) risk factors for oncogenic oral HPV persistence
Time frame: Baseline to end of four year follow-up and data abstraction/linkage.
HPV16 E6 antibodies present or absent in serum sample
To explore whether E6 and E7 seropositivity (to HPV16 or any oncogenic HPV) are markers for oncogenic oral HPV persistence among high-risk groups
Time frame: Baseline to end of four year follow-up and data abstraction/linkage.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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