The VOYAGER Study: HPV16 E6 Antibody Detection as an Early Marker of Oropharyngeal Cancer

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ABSTRACT Human papillomavirus (HPV) infection causes 6 different types of cancer – cervical, anal, vaginal, vulvar, penile and oropharyngeal cancer. While we have highly effective HPV vaccines, most of the US population is not vaccinated and is still at high risk for developing HPV-associated cancers. In the US, we have observed a rapid increase in HPV-driven oropharyngeal cancer (HPV-OPC), which is a type of throat cancer caused by HPV infection in the mouth and throat. Over the past few decades, the incidence of HPV-OPC has increased by over 200%. Kentucky has the highest rate of OPC in the US. Unlike cervical cancer, 85% of HPV-OPC cases occur among men and there is no method of early detection. While “pap testing” is highly effectively for the early detection of cervical cancer, this method does not work for HPV- OPC. Research gap: We need to develop new methods for early detection of HPV-OPC. We recently identified a promising early marker of HPV-OPC. The HPV16 E6 antibody marker is present in the blood in 90% of HPV-OPC patients at the time of diagnosis. When we tested blood samples stored years before men developed HPV-OPC, we found that the HPV16 E6 antibody marker could appear more than 10 years prior to HPV-OPC diagnosis. Additionally, we have shown that the HPV16 E6 antibody marker is highly specific for HPV-OPC and is not strongly associated with the 5 other cancers caused by HPV. The objective of the VOYAGER study is to better understand HPV16 E6 antibodies as a possible risk marker for HPV-OPC development among healthy men from the general population. 4,000 men will be recruited from 3 Appalachian Regional Health (ARH)-affiliated Primary Care Clinics and University of Kentucky (UK) Primary Care. Blood samples will be collected through a simple finger stick. Drops of blood will be collected on blood spot cards. The blood spot cards will be sent for HPV16 E6 antibody marker testing. For UK Primary Care patients, an additional oral rinse sample will be collected at enrollment to test for oral HPV infection. The aims of the study are to: (1) estimate how common the HPV16 E6 antibody marker is in the general healthy male population; (2) determine whether oral HPV infection is more common among men with the HPV16 E6 antibody marker and (3) determine whether men with the HPV16 E6 antibody marker are more likely to have undiagnosed HPV-OPC. We hypothesize that men with the HPV16 E6 antibody marker will be more likely to have an oral HPV infection and will be more likely to develop HPV-OPC than men without the HPV16 E6 antibody marker. Impact: These efforts could help to generate screening methods for early detection of HPV-OPC. This work is particularly impactful given that Kentucky has the highest rate of HPV-OPC in the country; and therefore, has the greatest need for methods of HPV-OPC early detection.
Effective start/end date6/1/226/30/23


  • Markey Cancer Center Foundation: $49,000.00


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