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Early Biomarkers for HPV-Driven Cancers: Modeling Risks and Screening

Award Number: R01CA307572
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/05/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2031

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Early Biomarkers for HPV-Driven Cancers: Modeling Risks and Screening - Summary The goal of this project is to offer Americans the possibility to benefit from early detection of oropharyngeal cancer. The incidence of oropharyngeal cancer caused by human papillomavirus (HPV-OPC) is highest in the US among all countries, and is increasing steeply over time. Antibodies to the HPV16-E6 oncoprotein, measured in blood, have >99% specificity and 90% sensitivity to detect HPV-OPC. HPV16-E6 is detectable up to 25 years prior to OPC diagnosis, and detects other HPV-related cancers with variable sensitivity. HPV16-E6 shows strong promise as a screening biomarker, in line with NCI’s National Cancer Plan which names early detection as one of four health-centric goals. However, evidence gaps impede use of HPV16-E6 to screen for HPV-OPC. First, for a person who is positive for HPV16-E6, their risk for non-oropharyngeal HPV-related cancers is unknown. Second, there is no evidence to support the choice of eligibility criteria and intervals for screening. Importantly, the US population of people living with HIV (PLHIV) is growing and aging, with increased risk for HPV-related cancers ranging from 2-fold (HPV-OPC) to 19-fold (anal cancer). We will: (1) Estimate the absolute risk of 7 HPV-related cancer types (OPC, anal, penis, cervix, vagina, vulva, and nasopharynx cancers) after an HPV16-E6 test result among HIV-negative people in the US. (2) Extend absolute risk calculations for 7 HPV-related cancer types after an HPV16-E6 test result to people living with HIV (PLHIV) in the US. (3) Model the potential impact of screening with HPV16-E6 in the US population based on different strategies for eligibility and screening interval, separately by HIV status. The risk and simulation models will be fully anchored in and tailored to the US population. However, the project must be led by the International Agency for Research on Cancer (IARC) because requires a data resource that is stored exclusively at IARC, the HPV Cancer Cohort Consortium (HPVC3). HPVC3 was NCI-funded during 2015-2021 and includes HPV16-E6 measurements from 1,050 HPV-related cancer cases and 6,221 controls. IARC's role as the lead institute is justified by its expertise in coordinating large international consortia and its ability to design and implement complex data harmonization protocols. Six US co-investigators will participate and contribute US surveillance, survey, and cohort data. The statistical framework will leverage best-available information on relative risks, while anchoring calculations to US population rates of disease and mortality.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $322,139 )
2026	2026	CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER	25 AVE TONY GARNIER	LYON 7TH				FRA	Cancer Detection and Diagnosis Research	000	1	9/7/2026	NEW	$322,139
2026	2026	CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER	25 AVE TONY GARNIER	LYON 7TH				FRA	Cancer Detection and Diagnosis Research	001	1	9/14/2026	NEW	$0
														Subtotal = $322,139

Grand Total All Awards = $322,139

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Early Biomarkers for HPV-Driven Cancers: Modeling Risks and Screening

Award Number: R01CA307572

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/05/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2031

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