Last updated on July 2019

Men and Women Offering Understanding of Throat HPV


Brief description of study

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.

Detailed Study Description

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 E6 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 (Johns Hopkins) and participants are being enrolled at three sites across the United States including Johns Hopkins (site Co-Is Dr. Amber D'Souza and Dr. Carole Fakhry), Icahn School of Medicine at Mt. Sinai (site PI Dr. Brett Miles) and Oregon Health and Science University (site PI Dr. Daniel Clayburgh) along with participants identified as having oncogenic oral HPV infection in a previous study.

Clinical Study Identifier: NCT03644563

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Johns Hopkins Hospital

Baltimore, MD United States
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Recruitment Status: Open


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